Quality Engineer III, R&D
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Description
Position Summary
Ensures, through global and local Product Development Process procedures and efforts, that Molecular products are developed, tested and transferred to manufacturing according to established procedures that will assure that they meet all quality requirements.
Responsible for the implementation and maintenance of effective Quality Systems in accordance with FDA Quality Systems Regulation, ISO 9001, ISO 13485 and other applicable country specific regulations.
Participates and provides guidance to quality improvement teams on tools, techniques and management systems for quality assurance, compliance, and continuous quality improvement.
Primary Duties
- Perform all work in compliance with company quality procedures and standards.
- Quality Engineering Support for the Molecular R&D Design Control Process – Design, approve, and implement development effort/project planning as needed, review and approve project documentation as requested.
- Represent the Quality R&D function by participating in design reviews, developing quality engineering deliverables and assuring Design History File (DHF) is updated and reviewed for accuracy/ completeness when necessary.
- Provide guidance / support to program directors, project managers, product development teams, R&D, and Product Validation functions regarding application of design controls, scalability, and related development process practices and improvements.
- Contribute to the documentation of quality systems and programs in the area of training, change management, design control, including product verification and validation, CAPA for relevant design issues, documentation control considerations, etc. to ensure compliance with FDA and regulatory requirements.
- Develop and execute design control training programs (e.g. design change control, risk analysis, etc. as requested).
- Prepare for and support regulatory and agency inspections/audits (FDA/ISO/MDSAP/etc.), investigations, and inquiries regarding the control and assessment of product design quality. Support corporate/internal design control audits.
- Participate in site R&D CAPA activities and non-conformities/deviations including investigation, effectiveness, and root cause analysis, etc. Coordinate implementation of corrective actions and preventive measures, as needed.
- Function as QA subject matter expert for cross-functional development team related practices: facilitate risk management activities, provide guidance for strategy and content of requirements and specifications. Provide strategies and approvals for verification methodologies, configuration management, validation, and regression testing approaches.
- Ensure the maintenance of the Risk Management File of the products in your portfolio
Training and Education
Required- Bachelor’s Degree in science or engineering discipline. Master’s degree in a scientific discipline is preferred, minimum (8) years of relevant Health Industry (IVD, MD, Biotech or Pharma) experience within R&D, Product Development, Design Controls, Technical support, QE/QA/QC or Regulatory Affairs required.
Knowledge in biology, and specially in molecular biology is preferred, but not required.
Must have exposure to and knowledge of the interpretation and application of relevant Domestic and International Regulations and Industry Standards (ISO 13485, 21CFR820, EN 62366, IEC 62304, ISO14971, 21CFR11, MDR 2017/746 and CLSI)
Requires effective written and oral communication skills to interact across all levels of the organization.
Must have experience in and knowledge of Microsoft Office Package (Word, Excel, etc.).
One or more of the following certifications is desired for this role: Certified Quality Engineering (CQE), Certified Quality Auditor (CQA), Certified Software Quality Engineer (CSQE), Certified Reliability Engineering (CRE), Certified Biomedical Auditor (BCA), or Six Sigma Black Belt.
Experience
Minimum 8-years previous on-the-job experience requiring professional communication and interactions utilizing skills outlined below
Previous experience in an Engineering, Scientific or Investigative role is required.
Demonstrated competence in the selection and use of Quality Engineering tools, techniques, and processes is preferred.
Experience in Quality Assurance, Quality Control, laboratory or life science or other manufacturing setting that has a formal quality system with involvement in Design controls is preferred.
Experience and/or education in biology, and specifically in molecular biology is preferred, but not required.
Master’s degree in relevant discipline is highly desired.
Knowledge, Skills, and Abilities
- Competent understanding of Design controls
- Technical writing skills
- Writing procedures, flowcharting
- Ability to collaborate cross-functionally
- Application of Quality Risk Management principles
- Attention to detail (e.g. document reviews, design reviews).
- High level of written and verbal communications skills
- Ability to communicate with R&D Engineering and perform risk analysis as instructed.
- Wisdom to seek help when needed.
- Proficiency in MS Office tools, including Outlook, Word, and Excel
Working Conditions and Physical Requirements
- Ability to remain in stationary position, often standing, for prolonged periods.
- Ability to ascend/descend stairs, ladders, ramps, and the like.
- Ability to wear PPE correctly most of the day.
- Ability to operate heavy machinery.
- Ability to adjust or move objects up to 50 pounds in all directions.
Domestic travel required 10% of time
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BioFire Diagnostics, LLC. is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran or disabled status, or genetic information.
Please be advised that the receipt of satisfactory responses to reference requests and the provision of satisfactory proof of an applicant’s identity and legal authorization to work in the United States are required of all new hires. Any misrepresentation, falsification, or material omission may result in the failure to receive an offer, the retraction of an offer, or if already hired, dismissal. If you are a qualified individual with a disability, you may request a reasonable accommodation in BioFire Diagnostics’ application process by contacting us via telephone at (385) 770-1132, by email at [email protected], or by dialing 711 for access to Telecommunications Relay Services (TRS).