Sr Quality Technician

Freudenberg · Jeffersonville, IN

The role in 30 seconds

An engineer-level quality role at Freudenberg (industrial) in Jeffersonville, IN. Advanced understanding of procedures and equipment.

They ask for: 5+ years · degree preferred
Tools it names: Root cause, CAPA, ISO 13485, FDA / GMP, Validation (IQ/OQ/PQ)

Read from the posting. The full description is below.

How this role compares

Against 23 other live quality postings in Indiana.

Skills these teams ask for most

✓ = this posting asks for it too. % = share of similar postings that mention it.

Stands out: this posting asks for CAPA, which few similar roles mention. If you have it, lead with it.

It asks for 5+ years. If you're close, apply anyway: requirements are a wish list. Talk to someone on the team first.

Pulled from the posting text. If it's not listed here, the posting didn't say.

Five moves over a week or two. The first one takes ten minutes.

1
Pick 2–3 people on the Quality team at Freudenberg
Engineers who joined in the last year or two reply the most. Use the team search on this page to find them.
2
Send a short, curious note
One real question about their work. No favors yet. Each person gets a different note, written for this role.
3
Turn a reply into a short call
Questions worth asking about this team:
- What does a normal week look like on your team?
- Which standards drive the work here: ISO 13485, IATF 16949, AS9100?
- How much of the job is customer complaints versus prevention?
- How did you land the job? What stood out in your interviews?
4
Apply with someone vouching for you
If the call went well, ask whether they’d pass your résumé to the hiring manager. Send your résumé link, apply that day, and let them know.
5
Bring proof to the interview
One page of before-and-after numbers from projects you led: scrap, OEE, cycle time, cost. Plant managers hire on results.

3 other open roles at this site.

Full description from FreudenbergAs posted on their careers site.Show

◆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.

✓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

ISO 13485 EU Medical Device Regulation (EU MDR) Good Manufacturing Practices (GMP)

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.

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Freudenberg Medical LLC

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Working at Freudenberg: We will wow your world!