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About the role
Key responsibilities & impact- Design Controls subject matter expert managing process and compliance supporting Abbott Diabetes Care R&D team
- Partner in optimizing, streamlining, and increasing compliance with design control requirements
- Lead process development and process improvement projects with cross-functional teams
- Conduct training on general design controls and specific to process changes
- Ensure conformity of processes and records to global regulatory standards and internal policies
- Audit design records as required to ensure conformance
- Perform gap analyses to international regulatory standards and propose policy updates
- Maintain expertise in global design controls and development standards and guidance
- Train and mentor R&D and QA resources
- Participate in audits as a R&D representative and design controls expert
Requirements
What you’ll need- BS in Management, Engineering or Science preferred, or equivalent work experience
- 5+ years Quality or R&D experience at a medical device company
- In-depth knowledge of the Quality System Regulation (QSR), ISO 13485, MDSAP, and EU Medical Device Regulation
- Experience leading design processes in a medical device company
- High level of knowledge of all QMS sub systems including: CAPA, internal audits, risk management, design control, verification and validation
- Must possess strong written, verbal and interpersonal communication skills
- Must be able to communicate globally and create followership
- Travel will be 25% including periodic international travel.
Benefits
Comp & perks- Health insurance
- Paid time off
- Professional development opportunities
- Retirement plans
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
design controlsprocess developmentprocess improvementgap analysisquality management system (QMS)CAPArisk managementverificationvalidationcompliance
Soft Skills
communicationleadershipmentoringtraininginterpersonal skillsglobal communicationfollowership
Certifications
BS in ManagementBS in EngineeringBS in Science