Quality Lead With Medical Device
talent groupsReedsville (PA)
About the role
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 standards
Key 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.
Required Skills:
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
Preferred Qualifications:
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
Before you apply
Applying takes about a minute. These four things decide how fast it moves after that.
Your profile is current
It's what we read first. Occupations, seniority and locations matter more than a long history.
Two examples you can talk through
Not a portfolio — just two pieces of work where you can explain the decisions and what you'd change.
A number in mind
What you're on now and what would make you move. We negotiate better when we know both.
Your notice period
Employers plan around it, and it's the question that stalls offers most often.
Once you apply, someone reads it and calls you before anything reaches the employer — usually within two working days.
More like this