Position Summary.

The Quality Control Technician I will be responsible for inspecting and testing Nuclein’s diagnostic medical devices, subassemblies, and components.  The role involves maintaining a high level of quality in the product by ensuring adherence to specifications, applying rigor, technical knowledge and skills to daily operations, and collaborating with team members.

Essential Duties and Responsibilities. 

        ·         Perform sampling and inspections in a laboratory environment       

        ·         Inspections can include visual, dimensional, optical, and functional/analytical tests

        ·         Maintain work area and equipment to GMP standards, perform equipment maintenance and metrology

        ·         Perform data analysis, records results, and archives quality records

        ·         Is proficient at reading and interpreting technical drawings, schematics, specifications, etc.

        ·         Recognizes and reports deviations, non-conformances, and out of specification events promptly and accurately, perform material quarantine

        ·         Reviews quality records for completeness, accuracy, and compliance

        ·         May participate in validation activities

        ·         May support quality audits

Education, Qualifications, and/or Experience. 

        ·         Associate’s degree or higher in a technical discipline or equivalent work experience

        ·         Minimum 1 year work experience preferred, experience in medical device or other regulated industry preferred

        ·         Quality certification, such as ASQ CQI, CQT or ASME GD&T preferred

        ·         Strong computer skills and experience with laboratory equipment

        ·         Strong attention to detail and problem solving skills

        ·         Familiarity with measurement tools, data processing, quality control principles and processes

        ·         Proficiency reviewing records for completeness and accuracy

·         Strong organizational and time management skills

Physical Requirements.  

·         Repetitive Motion: Picking and placing parts, use of laboratory equipment, computer use

·        Weight Lifting: < 50 lbs

·        Position: Sitting and standing

·        Speaking and communicating

·        Use of PPE may be required in laboratory/manufacturing/warehouse areas

THIS ROLE IS 100% ON SITE IN AUSTIN, TX - CANDIDATES MUST CURRENTLY RESIDE IN THE AUSTIN AREA - NO SPONSORSHIP IS OFFERED AT THIS TIME

The Quality Control (QC) Scientist II will support the development of, and maintain, key elements of the Nuclein quality management system. This role will provide support for QC activities related to incoming, component and finished product release and development of the Nuclein QC laboratory. In collaboration with Assay Development, Operations, and Engineering colleagues, the QC Scientist II will ensure that Nuclein products meet the highest standards of quality and are compliant with all applicable regulations.

Essential Duties and Responsibilities. 

·         Executes QC testing and inspection of materials for release to production and finished product testing, including record review for compliance

·         Authors, reviews, and executes QC test methods and procedures as a subject matter expert

·         Develops and reviews test method validation/verification protocols and reports

·         Supports the development and maintenance of QC laboratory, including authoring of Standard Operating Procedures (SOPs) for QC lab personnel

·         Supports day-to-day QC lab operations, including ordering/receiving supplies and operating/maintaining laboratory equipment

·         Supports investigations into deviations, non-conformances, and CAPAs, including authoring and approval of investigation records

·         Mentors QC Technicians

·         Ensures compliance to 21 CFR Part 820, ISO 13485, and other applicable regulations by providing support through interpretation of regulations and leading improvement initiative

·         Supports internal and external inspections/audits

        ·         Performs other duties and responsibilities as assigned by management, including leading cross-functional tasks                

Education, Qualifications, and/or Experience. 

·         Bachelor’s degree in a Science, such as Molecular Biology, Chemistry, Biomedical Sciences or related technical field

·         At least 5 years of experience in a laboratory setting, preferably within a medical device ISO 13485 environment, or similar FDA regulated industry

·         Experience working with IVDs preferred (PCR technology/platform a plus)

·         Hands-on experience in DNA, RNA, PCR and general molecular biology laboratory techniques preferred

·         Ability to properly operate laboratory tools and equipment including pipettes, centrifuges, vortex mixers, incubators, PCR enclosures, biosafety cabinet, refrigerators and freezers

·         Familiar with statistical techniques for determine QC criteria and sample size

·         Ability to perform repetitive testing with a high level of attention to detail

·         Have excellent written and verbal communication skills – able to train others in quality principles and operations

Physical Requirements.  

·         Repetitive Motion: Mostly computer use

·         Weight Lifting: < 25 lbs

·         Position: Standing and sitting

·         Occasional use of PPE may be required in laboratory/manufacturing/warehouse areas

        Local candidates only. Sponsorship is not being offered at this time. No recruiters or agencies, please. 

The Manufacturing Engineer provides technical support to Nuclein cGMP manufacturing operations. This role will focus on instrument and cartridge production and production support. Position interfaces directly with Quality Assurance, Production Personnel, Supply Chain, Engineering and Assay Development to ensure the on-time delivery of high-quality devices in line with company growth and supply demands.

Essential Duties and Responsibilities:

• Lead and manage manufacturing engineering activities such as validations, test equipment design, test procedure development, process development and automation equipment implementation.
• Work with Development groups for the implementation of engineering changes to the manufacturing process
• Monitor production metrics and implement proactive corrective actions and process efficiency improvements as needed.
• Develop equipment, fixtures and tools that are needed for the manufacturing process.
• Ensure strict adherence to FDA regulations and GMP guidelines through process development and oversight.
• Resolve CAPAs and product Non-Conformances for the factory floor including supporting MRB functions
• Support 3rd party compliance audits.
• Provide technical support for Design for Manufacturability and product changes
• Foster a culture of teamwork, accountability, and continuous improvement.
• Develop Manufacturing Instructions as required.  Including training to Direct Labor as needed
• Develop and train processes to improve compliance and accountability such as Line Clearance and Label Line Clearance
• Implement lean manufacturing principles to streamline operations.
• Support development and direct support of instrument assembly manufacturing lines identifying needed equipment and test fixtures.  Including process development, maintenance, training, and monitoring
• Work directly with suppliers to resolve Materials issues.
• Develop BOMs, routings and other manufacturing process documentation as required
•  Support returned product rework and repair including work instruction and test procedure development

Education, Qualifications, and/or Experience:

• Bachelor’s degree in a relevant field
• 3+ years of experience in manufacturing engineering support responsibilities in the medical device industry.  Specifically in instrument manufacturing is desired
• Experience operating in environments of FDA regulations and cGMP guidelines such as CFR820 and ISO13485-2016 is desired.
• Excellent problem-solving and decision-making skills.
• Demonstrated ability to drive process improvements and cost reductions.
• Ability to work collaboratively, explain the ‘Why,’ and be able to influence others in a fast-paced environment
• Ability to operate independently with moderate supervision
• Possess a high level of attention to detail and organization
• Ability to prioritize tasks and to delegate them when appropriate
• Proficient with Microsoft Office Suite or related software to complete reports and logs
• Must be able to traverse the facility
• Must be able to lift 25 pounds at a time

Physical Requirements.

• Repetitive Motion: Mostly computer use
• Weight Lifting: > 25 lbs
• Position: Mostly sitting
• Speaking and communicating
• Occasional use of PPE may be required in laboratory/manufacturing/warehouse areas

THIS POSITION IS 100% ONSITE IN AUSTIN, TX. CANDIDATES MUST CURRENTLY LIVE WITHIN COMMUTING DISTANCE TO BE CONSIDERED. NO SPONSORSHIP IS BEING OFFERED AT THIS TIME.

The Staff Quality Engineer will support the development, and maintain key elements, of the Nuclein quality management system. Reporting to the Associate Director, Product Quality, this role will provide quality oversight of activities surrounding production, design and compliance. In collaboration with Operations, Engineering, and Assay Development colleagues and Nuclein’s suppliers, the Staff Quality Engineer ensures that our products meet the highest standards of quality and are compliant with all applicable regulations. This role handles escalated issues independently and proposes practical solutions to resolve challenges and make improvements. Serves as Subject Matter Expert in at least one quality discipline, such as Risk Management, Process Validation, Design Control, etc. This role is intended to be multi-disciplinary supporting production, design and regulatory efforts as needed.

Essential Duties and Responsibilities. 

·         Ensures manufacturing and testing of medical device IVDs is performed in accordance with Nuclein procedures and Good Manufacturing Practices (GMPs)

·         Completes documentation to the standard for external Regulatory Body review

·         Reviews and approves manufacturing and testing/inspection records, and authorizes product release

·         Leads the generation/approval of documents related to equipment qualification, facility qualification, process validation, test method validation, and risk management (PFMEA, hazard analysis, etc.)

·         Generates/reviews/approves equipment specifications, calibration/preventive maintenance reports, Nonconformances, Deviations and other quality records

·         Leads cross functional teams on complex projects achieving timelines and mentors others on the principles of quality

·         Quality representative for complex on-market design changes, new product development and regulatory submissions

·         Facilitates the Nuclein supplier quality management program and guides cross-functional partners through supplier selection, change control, and qualification processes

o    Conducts supplier audits (up to 10% travel)

o    Manages supplier change requests, notifications, deviations, and corrective action requests

·         Reviews/approves in complaints and related investigative activities

·         Leads the development and improvement of the QMS through the creation of processes and authoring of procedures

                   ·         Hosts internal and external inspections/audits

                   ·         Manages external resources responsibly

        ·         Performs other duties and responsibilities as assigned by management

Education, Qualifications, and/or Experience. 

·         B.S in Engineering or Science related field or equivalent experience required.

·         10+ years experience in a quality field required, experience in medical device ISO 13485 environment, or similar FDA regulated industry required

·         Experience working with IVDs preferred (PCR technology/platform a plus)

·         Expert experience in at least one quality discipline

·         Experience interfacing directly with external resources (suppliers, regulatory bodies, consultants)

·         Demonstrated ability to lead cross functional teams to achieve timelines

        ·         Have excellent written and verbal communication skills, with ability to train others in quality principles and operations

Physical Requirements.  

                  ·         Repetitive Motion: Mostly computer use

               ·         Weight Lifting: < 25 lbs  

                  ·         Position: Mostly sitting

               ·         Occasional use of PPE may be required in laboratory/manufacturing/warehouse areas

CANDIDATES MUST CURRENTLY LIVE IN THE AUSTIN, TX AREA - NO SPONSORSHIP IS OFFERED AT THIS TIME

The Buyer I will be responsible for the purchasing of floor stock items, services and miscellaneous purchase requests to support manufacturing. This role will also support inventory related activities, such as cycle counting and picking of inventory to support manufacturing. 

Essential Duties and Responsibilities. 

·         Reviews MRP messages and Issues PO’s for inventory to support the demand plan.

·         Places orders to maintain PAR levels of all floor stock items.

·         Issues PO’s as requested for non-inventory items or services and tracks approval status. 

·         Manages and orders supplies (Shipping supplies & manufacturing supplies)

·         Contact vendors to obtain information regarding shipping status of orders or special orders placed by department.

·         Request RMA’s from suppliers and processes returns to suppliers in the ERP system.

·         Track inbound shipments from the time they are in-transit until they are delivered to destination.

·         Follows up with suppliers to resolve receiving variances.

·         Supports warehouse activities in cycle counting of inventory and components as determined by the program and research variances.

·         Processes and picks work orders in the ERP system to support production schedules.

·         Assists the warehouse team with picking, packing, and processing of sales orders of finished goods in the ERP system; arranges for shipment of orders by delivery date on order.

·         Works with outside partners such as FedEx, UPS, and inventory suppliers.

·         Organizes and labels inventory areas with appropriate descriptions.

·         Performs inventory analysis and reporting in Excel to support inventory management and planning decisions.

·         Supports material planning activities as needed. 

·         Other duties as assigned to support the company 

Education, Qualifications, and/or Experience. 

·         Bachelor’s degree in Business Management or a Purchasing Certification preferred

·         Minimum of 1 year manufacturing procurement support in lieu of degree or certification can be considered

·         Outstanding prioritization, time management and organizational skills

·         Strong attention to detail and outstanding problem-solving skills.

·         Desire to learn & improve processes.

·         Ability to learn new software systems

·         Professional communication skills

·         Positive attitude in contributing to other areas outside job responsibilities.

·         Works effectively with other departments 

·         Skill in basic arithmetic.

·         Fluent in English

·         Microsoft Office (Outlook, Word and Excel) experience with proficiency in Excel

Physical Requirements.  

·         Repetitive Motion: Mostly computer use

·         Weight Lifting: < 40 lbs

·         Position: Mostly sitting with some standing and lifting in the warehouse

·         Speaking and communicating

·         Occasional use of PPE may be required in laboratory/manufacturing/warehouse areas 

CANDIDATES MUST CURRENTLY LIVE IN THE AUSTIN,TX AREA - NO SPONSORSHIP IS BEING OFFERED AT THIS TIME