Senior Design QA Engineer
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Job Location:
Monthly Salary:
Posted on:
5 days ago
Vacancies:
1 Vacancy
Job Summary
About the Role
In this role you will lead end-to-end design quality activities for new products ensuring they meet the highest standards of safety reliability and compliance. You will work closely with cross-functional R&D and engineering teams to implement robust design controls support the full product development lifecycle and help bring high impact genomic and scientific solutions to market.
Responsibilities
- Lead Design Controls activities provide guidance to Product Development Teams on Design inputs and outputs V&V Risk Management Design Reviews Design Changes and Design Transfer.
- Conduct/lead/support Risk analysis activities and implementation of risk controls to ensure that products are safe and effective.
- Lead and support product development teams through processes to ensure design robustness processes include: reliability statistics software and human factors.
- Ensure product development activities are conducted in compliance with all applicable regulatory requirements international standards and internal procedures.
- Collaborate across functions and provide oversight for the satisfactory resolution of quality and compliance issues.
- Ensure that the product Design History File is auditable traceable and complete. Serve as the Authority on the DHF for external regulatory inspections and audits.
Education
- BS degree in Engineering or in a Science field such as Chemistry Microbiology Biology or Biochemistry.
- 5 years of Quality or equivalent experience or a combination of work experience and education in a Quality/Quality related field (QE QA QC Supplier Quality)
- 1 years of experience in New Product Introduction activities
- 1 years of working in the Medical Device In-Vitro Diagnostics or other regulated industry
- Solid understanding of product development lifecycles design change and change control risk management product and process V&V methodologies Design Transfer and manufacturing/ production process control methodologies.
- Experience with applicable FDA European and other relevant clinical/regulatory requirements and international standards including ISO 9001 ISO 13485 ISO 14971 EU IVDR/MDR 21CFR 820 Quality System Regulation etc. desired.
- ASQ certifications (CQA CQE CRE Six Sigma etc.) desired.
- Strong verbal and written communication skills at multiple levels in the organization.
- Ability to work optimally within a team in a fast-paced changing environment.
- Strong impact and influence including the ability to provide feedback to build positive relationships and improve business results.
- Ability to travel.
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Key Skills
- Electrical Engineering
- SOC
- PCB
- Warehouse Management
- Warehouse Experience
- CAD
- Creo
- SolidWorks
- Data Mining
- Digital design
- Mechanical Engineering
- Autocad
