Quality Lead
•Today
| Hours | Full-time, Part-time |
|---|---|
| Location | Reedsville, PA Reedsville, Pennsylvania open_in_new |
About this job
Job Description
Job Description
Role: Quality Lead
Location: Reedsville, PA (Day 1 Onsite)Job Summary: Support quality remediation and compliance initiatives by managing nonconformance, CAPA, deviation, complaint handling, and quality system activities. Perform quality assessments, root cause investigations, data analysis, and quality improvement initiatives while ensuring compliance with medical device regulations and standardsKey Responsibilities:
Location: Reedsville, PA (Day 1 Onsite)Job Summary: Support quality remediation and compliance initiatives by managing nonconformance, CAPA, deviation, complaint handling, and quality system activities. Perform quality assessments, root cause investigations, data analysis, and quality improvement initiatives while ensuring compliance with medical device regulations and standardsKey Responsibilities:
- Manage CAPA, Nonconformance, and Deviation activities.
- Conduct Root Cause Analysis and corrective actions.
- Review quality metrics and identify recurring issues.
- Support quality audits and FDA readiness programs.
- Collaborate with cross-functional teams on quality improvements.
- CAPA, Nonconformance, and Deviation Management.
- Root Cause Analysis (5 Why, Fishbone, FTA).
- Quality Metrics and Trend Analysis.
- FDA 21 CFR Part 820, ISO 13485, ISO 14971.
- Design Controls and Validation Support
- Bachelor's degree in Engineering discipline.
- 8 years of Medical Device Quality experience.
- Experience with Class II/III medical devices.
- Experience supporting FDA, MDSAP, and ISO audits
Nearby locations
Nearby Job Titles
Fast Food Preparation Worker Jobs Driver Jobs Truck Driver Jobs Services Sales Representative Jobs Radiologic Technologist JobsNearby Locations
State College, PA Jobs Lewistown, PA Jobs Bellefonte, PA Jobs Mifflintown, PA Jobs Pennsylvania JobsNearby Companies
DoorDash Jobs U.S. Navy Jobs HMG Careers Jobs Giving Tree Surrogacy Jobs Reeledge JobsNearby Categories
Full-time Jobs Part-time Jobs Gig Jobs Posting ID: 1309830195 Posted: 2026-10-30 Job Title: Quality Lead
Your Privacy Choices