Design Controls Manager
Abbott
full-time
Posted on:
Location Type: Remote
Location: United States
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Salary
💰 $99,300 - $198,700 per year
About the role
- Design Controls subject matter expert managing process and compliance to process supporting Abbott Diabetes Care R&D team.
- Interfaces directly with Regulatory, Quality, Operations, and R&D directors, managers and SMEs to ensure that the design controls and related processes meet global regulatory standards and guidance while promoting efficiency.
- Partner in optimizing, streamlining, and increasing compliance with design control requirements for Abbott Diabetes Care products.
- Lead process development and process improvement projects with world-wide cross-functional teams.
- Conduct training on general design controls.
- Develop and deliver training specific to process changes.
- Demonstrate leadership in change management practices.
- Ensure conformity of processes and records to global regulatory standards and internal policies and procedures.
- Audit design records as required to ensure conformance; work with R&D and QA teams to evaluate and remediate non-conformances.
- Maintain expertise in global design controls and design and development standards and guidance including ISO13485, ISO14971, 21CFRPart820, MDSAP, IEC60601, IEC62304, IEC62366, Agile software development, etc.
- Train and mentor R&D and QA resources in subject matter expertise to ensure alignment and acceptance of organization with policies and procedures.
Requirements
- BS in Management, Engineering or Science preferred, or equivalent combination of work experience and education.
- 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.
- High level of knowledge of all QMS sub systems including: CAPA, internal audits, risk management, design control, verification and validation, internal and external audits, management responsibility, training.
- Experience leading a design and/or design processes in a medical device company which includes software as a medical device product.
- Demonstrated leadership through influence.
- Must be able to communicate globally and create followership.
- Must possess strong written, verbal and interpersonal communication skills and work independently as well as in close collaboration with others.
Benefits
- None specified 📊 Check your resume score for this job Improve your chances of getting an interview by checking your resume score before you apply. Check Resume Score
Applicant Tracking System Keywords
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Hard Skills & Tools
design controlsprocess developmentprocess improvementtrainingchange managementauditingrisk managementverification and validationAgile software developmentmedical device design
Soft Skills
leadershipcommunicationcollaborationinfluencementoringindependenceinterpersonal skillstraining deliveryglobal communicationfollowership
Certifications
ISO 13485MDSAP21 CFR Part 820IEC 60601IEC 62304IEC 62366