• 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 (5) 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.
• In lieu of degree and type: +5 Years In Quality Control or Quality Assurance

Experience:

• Minimum 5-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, 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