The Design Assurance Engineer acts as the quality representative on design core teams for electromechanical instruments, reagents and assays for the life science and in-vitro diagnostics market. Design Assurance Engineer is responsible for guiding the development teams through the Design Control process ensuring compliance with FDA, ISO, QSR, quality, safety and environmental regulations and internal procedures. The Design Assurance Engineer may also provide support for quality initiatives, post market design changes/improvements and quality surveillance activities.
What you will do
- Participates on design core teams utilizing experience to guide team members through the Design Control processes to achieve business, operational, quality and safety goals for new products.
- Assists team members in the creation and maintenance design deliverables (Design & Development Plans, Inputs/Outputs, Protocols, Matrices, etc) are completed on-time and per regulations.
- Guides the risk management process for design teams through the creation of risk documents ensuring all risks are appropriately identified, mitigated and verified.
- Recommends rationale, including statistical tools, for protocol structure.
- Acts as a resource within and cross departmental for design control related questions & challenges
- Coaches departmental personnel in the engineer’s area of responsibility.
- Supports quality system training and participates in the development of training programs
- Acts as escort and/or supports during external audits/inspections
- Other duties as assigned.
- Bachelor's Degree Bachelor degree required, in a life science/engineering discipline required
- 1+ Years Experience in an Good Manufacturing Practices (GMP) environment required, preferably in medical device industry preferred
- 1+ Years Working knowledge of current industry quality practices under QSRs, ISO-13485 and international regulations preferred
- 1+ Years Experience as a member of a design team preferred
- 5+ Years experience in regulated environment required, previous design assurance experience preferred
- 1+ Years Experience with medical device risk management (ISO 14971) is preferred
- 1+ Years Experience with usability (ISO 62366) is preferred
Training and Skills
- Excellent interpersonal, verbal and written communication skills
- Certification in a quality discipline preferred, such as CQM, CQA, CQE, etc.
- Strong computer skills (Microsoft Windows and Office programs), familiarity with Oracle preferred
- High degree of problem solving and analytical skills
- Ability to apply statistical tools
- Strong organizational and time-management skills
Very competitive salary and benefits!
Great company to work for!
Full relocation package is available!
Don't miss out! Apply now and we'll be in touch immediately with more specific details, salary information and to answer any questions!!
This position does NOT provide sponsorship so please do NOT apply if you require sponsorship. Thank You
KP Recruiting Group
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