Sr Quality Technician
- Location
- Jeffersonville, IN · On-site
- Job type
- Full-time
- Level
- Senior
- Experience
- 3+ years
- Education
- Bachelor's degree
- Listed
- 21 days ago
Skills & highlights for this role
- FDA 21 CFR Part 820
- ISO 13485
- CAPA
- root cause analysis
- GMP
Also useful
- EU MDR
- process validation
- risk management
About the role
Working at Freudenberg: We will wow your world!
Responsibilities
- Advanced understanding of procedures and equipment.
- Resolves most issues independently.
- Prioritizes tasks and supports training.
- Leads by example and formally trains junior staff or acts as a resource for colleagues with less experience.
- Proficient in applying FDA regulations (21 CFR Part 820), ISO 13485, and other relevant standards.
- Strong understanding of GMP principles and quality assurance practices.
- Skilled in product testing, inspection, and statistical quality control.
- Proficient in risk management methodologies and post-market surveillance.
- Ability to lead CAPA investigations and implement sustainable corrective actions.
- Familiarity with design control processes to ensure compliance with performance criteria.
- Participation in internal and external audits.
Qualifications
3-5+ years of experience in the medical device industry, including at least 3 years in Quality Engineering or Quality Systems. Proven experience with nonconformance management, CAPA, root cause analysis, and product quality. Bachelor's degree in Engineering, Quality, Biomedical Engineering, or a related technical field preferred will take experience in lieu of degree Experience working within a regulated manufacturing environment.
Strong working knowledge of medical device quality and regulatory requirements, including: FDA Quality System requirements ISO 13485 EU Medical Device Regulation (EU MDR) Good Manufacturing Practices (GMP) Understanding of quality system requirements and industry best practices. Experience managing and investigating nonconformances. Experience leading CAPA activities and root cause investigations.
- Experience with process validation and manufacturing process controls.
- Experience with change control and change management.
- Experience with software validation, as applicable.
- Ability to analyze quality data, identify trends, and drive corrective and preventive actions.
- Experience partnering with Manufacturing, Engineering, Operations, and other cross-functional teams to resolve quality issues.
- Freudenberg Medical LLC
Equal opportunity and legal notices
The Freudenberg Group is an equal opportunity employer that is committed to diversity and inclusion. Employment opportunities are available to all applicants and associates without regard to race, color, religion, creed, gender (including pregnancy, childbirth, breastfeeding, or related medical conditions), gender identity or expression, national origin, ancestry, age, mental or physical disability, genetic information, marital status, familial status, sexual orientation, protected military or veteran status, or any other characteristic protected by applicable law.
From Freudenberg's careers page, first listed on Rolev.ai on October 20, 2026. Rolev.ai is not the employer.
How Rolev.ai helps with this application
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Common questions
Where is the Sr Quality Technician job at Freudenberg located?
This Sr Quality Technician position at Freudenberg is located in Jeffersonville, IN (On-site). Always check Freudenberg's application page for specific state eligibility or relocation policies.
What qualifications are required for Sr Quality Technician at Freudenberg?
For the Sr Quality Technician role, Freudenberg highlights 3+ years of relevant experience; a bachelor's degree; experience with FDA 21 CFR Part 820, ISO 13485, CAPA, root cause analysis, GMP. Rolev.ai can score your existing resume against these requirements and show any skill gaps before you apply.
How do I apply for the Sr Quality Technician position at Freudenberg?
This listing links directly to Freudenberg's Workday application page. You can apply directly on Freudenberg's site, or use Rolev.ai to check your resume fit, generate a zero-hallucination tailored resume and cover letter for this posting, and autofill the Workday application form in 1 click with the Rolev.ai Chrome extension. You always review the form and press Submit yourself.