FREE ACCESS
5,000–10,000 jobs/day
See all jobs on Scoutfield
Search thousands of fresh jobs every day.
Discover
- Fresh listings
- Fast filters
- No subscription required
Create a free account and start exploring right away.
About the role
Key responsibilities & impact- Partner with leadership to resource, execute, and enforce business goals while aligning with ISO 13485, 21 CFR 820, ISO 14971, and global regulatory standards
- Own and uphold site-level QMS compliance with customer quality requirements, registrar standards, and regulatory agency mandates
- Serve as Management Representative and drive FDA/Notified Body audit readiness
- Participate in centralized Hub-and-Spoke CQP harmonization sprints
- Direct rapid resolution of non-conformances through root-cause-driven CAPAs
- Institutionalize systemic lessons learned across multi-site operations
- Measure Quality KPIs and drive quality performance with manufacturing, divisional operations, and quality leaders
- Design, deploy, and maintain an executive Quality Dashboard tracking FPY, CoPQ, NC timeliness, and CAPA cycle times
- Lead site Quality Engineering and Inspection teams to maximize FPY and eliminate waste through MRB oversight and zero-defect initiatives
- Lead customer quality relations, complaint investigations, root-cause analyses, RMAs, and service-level reporting
- Collaborate with Supplier Quality Engineering on incoming inspection protocols, supplier non-conformances, and SCAR closure
- Lead executive Quality Management Reviews, escalate systemic risks, and drive continuous improvement
- Recruit, mentor, and develop quality engineering and compliance personnel
Requirements
What you’ll need- Bachelor’s degree in Mechanical, Chemical, Material Science, Plastics, or related engineering/technical field
- 12+ years of related experience in medical device manufacturing with proven leadership experience
- Deep working knowledge of ISO 13485, ISO 14971, ISO 17025, MDSAP, and 21 CFR 820
- Expertise in QMS design/implementation
- Expertise in root cause analysis methodologies, including 5-Why, Fishbone, and 8D
- Expertise in Design Controls / NPI transfers
- Expertise in statistical process control (SPC)
- Expertise in Design of Experiments (DOE)
- Expertise in Lean Manufacturing and Six Sigma
- Willingness to travel 20%–25%
Benefits
Comp & perks- Medical/Dental/Vision Insurance
- Short-Term Disability
- Long-Term Disability
- Life Insurance
- Paid Vacation Days
- Paid Holidays
- 401k