INGENYX- Senior Quality Engineer - Sterility Assurance & Validation
Teleflex · Massachusetts
- Level
- Senior
- Team
- Quality
- Base pay
- $116k–$140k
- Travel
- 50%
- Degree
- Required
- Experience asked
- 7+ years
- Industry
- Medical devices
- Posted
- Recently
The role in 30 seconds
A senior quality role at Teleflex (medical devices) in Massachusetts.
- They ask for
- 7+ years · degree required
- Tools it names
- Root cause, FMEA, CAPA, ISO 13485, FDA / GMP, Validation (IQ/OQ/PQ)
- Base pay
- $116k–$140k
- Day to day
- about 50% travel
Read from the posting. The full description is below.
From the plant jobs report · week of October 19, 2026
Quality Engineer roles in Massachusetts: typical posted base $107k–$149k. This one lists $116k–$140k.
Median of the low and high ends of 50 live postings that list pay, out of 70 quality engineer openings in Massachusetts, read from manufacturers' own careers sites.
Massachusetts plant jobs report →Pay by team and state →What moves pay →
How this role compares
Against 69 other live quality postings in Massachusetts.
- Base pay
- About 7% above similar roles
- Experience asked
- More than usual (7+ vs 5+)
Typical $100k–$138k, from 38 postings that list pay.
Similar roles usually ask 5+ years.
Skills these teams ask for most
- ✓ Root cause 69%
- ✓ FDA / GMP 60%
- ✓ Validation (IQ/OQ/PQ) 51%
- ✓ CAPA 50%
- ✓ ISO 13485 46%
- ✓ FMEA 37%
✓ = this posting asks for it too. % = share of similar postings that mention it.
Stands out: this posting asks for Extrusion, which few similar roles mention. If you have it, lead with it.
At a glance
Pulled from the posting text. If it's not listed here, the posting didn't say.
How to get in at this plant
Five moves over a week or two. The first one takes ten minutes.
- 1
Pick 2–3 people on the Quality team at Teleflex
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?
- The posting says about 50% travel. Between which sites?
- 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.
Full description from TeleflexAs posted on their careers site.ShowHide
Position Summary
We are seeking an experienced Senior Quality Engineer – Sterility Assurance & Validation to serve as the internal technical owner for sterilization and sterility assurance activities while also supporting broader Quality Engineering and process validation needs.
This is a hands-on technical role with responsibility for maintaining validated sterilization processes, providing oversight of contract sterilization providers, supporting microbiological control activities, and ensuring continued compliance with applicable regulatory and quality system requirements.
The ideal candidate brings strong medical device Quality Engineering experience with demonstrated expertise in EO and radiation sterilization, process validation, and sterility assurance.
Principal
Requirements
- ✓Bachelor's degree in Engineering, Life Sciences, Microbiology, or a related technical discipline.
- ✓7+ years of Quality Engineering, Validation, Sterility Assurance, or related experience within the medical device industry.
- ✓Demonstrated experience with medical device sterilization processes, preferably including EO and radiation sterilization.
- ✓Strong experience with process validation and maintenance of validated processes.
- ✓Working knowledge of:
o ISO 11135 – Ethylene oxide sterilization
o ISO 11137 – Radiation sterilization
o ISO 11737 – Bioburden and sterility testing
o ISO 13485
o FDA medical device Quality System
requirements
- ✓Experience investigating sterilization deviations, process excursions, nonconformances, and CAPAs.
- ✓Experience working with contract sterilization providers and/or external testing laboratories.
- ✓Ability to independently assess technical information, make risk-based recommendations, and clearly document conclusions.
- ✓Strong cross-functional communication and technical writing skills.
Specialized Skills / Other
Requirements
- ✓Experience with both EO and gamma radiation sterilization.
- ✓Experience with sterilization cycle transfer, duplication, or establishment of new sterilization cycles.
- ✓Experience with bioburden trending and microbiological control programs.
- ✓Experience with radiation dose audits and dose-maintenance programs.
- ✓Experience supporting regulatory or Notified Body audits involving sterilization.
- ✓Experience in contract manufacturing or multi-site medical device environment.
- ✓ASQ CQE or other relevant Quality/Validation certification, preferred.
What Success Looks Like
The successful candidate will establish strong internal ownership of Sterility Assurance while effectively leveraging external laboratories and specialized SMEs
Show full description ↓Show less ↑
Expected Travel : Up to 50%
Ingenyx proudly launched as a new, independent company following its divestiture from Teleflex on August 3, 2026.
Ingenyx is a leading global provider of product development and production services for medical device manufacturers. We set ourselves apart with deep expertise, decades of experience, a dedication to design for manufacturability, and extensive, in-house capabilities, which include engineering, regulatory services, material selection and formulation, prototyping, manufacturing, assembly and packaging. We deliver industry-changing innovations and next-generation solutions for extrusions; diagnostic and interventional catheters; balloons and balloon catheters; sheath/dilator sets; specialty sutures, braids and fibers; and bioabsorbable sutures, yarns and resins. Join a dynamic, growing team that offers healthcare providers an array of medical technology solutions that make a difference in patients’ lives.
For more information, please visit Ingenyx.com
Sterility Assurance & Sterilization
- •Serve as the internal technical owner for the Sterility Assurance program.
- •Provide technical oversight of ethylene oxide (EO) and radiation sterilization processes.
- •Support sterilization cycle transfer, validation, requalification, and maintenance of the validated state.
- •Review and approve sterilization qualification and requalification protocols and reports.
- •Review sterilization cycle deviations, excursions, nonconformances, and change assessments.
- •Support investigation, root cause analysis, CAPA, and risk assessment for sterilization-related issues.
- •Coordinate and review annual Sterility Assurance and bioburden technical assessments.
- •Provide oversight of radiation dose audits, including review of Quarterly Dose Audit results, as applicable.
- •Monitor bioburden data and trends and coordinate specialized microbiology support when required.
- •Provide technical oversight of contract sterilizers and support supplier qualification, audits, SCARs, and quality agreements.
- •Maintain sterilization procedures, technical documentation, validation records, and required periodic reviews.
- •Support regulatory inspections, certification audits, customer audits, and technical inquiries related to sterilization and sterility assurance.
- •Partner with external microbiology laboratories and specialized Sterilization/Microbiology SMEs as required.
Quality Engineering & Validation
- •Support manufacturing process validation activities, including IQ, OQ, and PQ.
- •Provide Quality Engineering support for manufacturing processes, process changes, equipment qualification, and technology transfers.
- •Review and approve validation protocols, reports, engineering studies, and associated quality records.
- •Support nonconformance investigations, deviations, CAPAs, and root cause analysis.
- •Participate in manufacturing and process risk management activities, including PFMEAs and change assessments.
- •Apply appropriate statistical techniques to validation, process monitoring, and problem-solving activities.
- •Partner with Operations, Engineering, Supplier Quality, Regulatory Affairs, and other Quality functions to maintain compliant and capable manufacturing processes.
- •Support continuous improvement and risk-reduction initiatives.