Product Quality Assurance Engineer
ZOLL Medical · Chelmsford, MA
- Level
- Engineer
- Team
- Quality
- Base pay
- $82k–$90k
- Degree
- Required
- Experience asked
- 2+ years
- Industry
- Medical devices
- Posted
- 30+ days ago
The role in 30 seconds
An engineer-level quality role at ZOLL Medical (medical devices) in Chelmsford, MA. H1B, TN, STEM, OPT, etc.) either now or in the future.
- They ask for
- 2+ years · degree required
- Tools it names
- Root cause, CAPA, ISO 13485, FDA / GMP, Validation (IQ/OQ/PQ), Supplier quality
- Base pay
- $82k–$90k
Read from the posting. The full description is below.
How this role compares
Against 56 other live quality postings in Massachusetts.
- Base pay
- About 24% below similar roles
- Experience asked
- Less than usual (2+ vs 5+)
Typical $97k–$131k, from 34 postings that list pay.
Similar roles usually ask 5+ years.
Skills these teams ask for most
- ✓ Root cause 72%
- ✓ FDA / GMP 53%
- ✓ Validation (IQ/OQ/PQ) 53%
- ✓ ISO 13485 47%
- FMEA 44%
- ✓ CAPA 44%
✓ = this posting asks for it too. % = share of similar postings that mention 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 ZOLL Medical
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.
This plant: ZOLL Medical in Chelmsford
2 other open roles at this site.
- Quality Assurance Engineer · Quality
- Operational Excellence Partner · Lean / CI · Specialist
Full description from ZOLL MedicalAs posted on their careers site.ShowHide
requirements
of this position, applicants are expected to reside within a reasonable commuting distance of the designated work location (Chelmsford, MA). This role does not offer relocation.
ZOLL Medical does not provide immigration-related sponsorship for this role. Do not apply for this role if you will need ZOLL immigration sponsorship (e.g. H1B, TN, STEM, OPT, etc.) either now or in the future.
Job Summary
The Product Quality Assurance Engineer supports product quality throughout the product lifecycle, with a focus on complaint investigations, risk management support, and product quality monitoring. This role partners with Engineering, Manufacturing, Regulatory, and Post-Market teams to support investigations, analyze product performance, and contribute to activities that improve product reliability, patient safety, and compliance for medical devices.
Essential Functions
- ◆Assist with product and complaint investigations, including data gathering, product failure analysis, and support for root cause analysis activities.
- ◆Support product risk management activities, including documentation updates, risk assessments, and maintenance of risk management files in accordance with applicable standards and procedures.
- ◆Analyze complaint, service, and field performance data to identify trends, recurring issues, and opportunities for product quality improvement.
- ◆Support CAPA and nonconformance activities related to product quality issues, including documentation, tracking, and follow-up actions.
- ◆Participate in product design reviews and quality assessments to help ensure quality
requirements
are addressed throughout the product lifecycle.
- ✓Partner with Design Assurance, R&D, Manufacturing, Supplier Quality, Regulatory Affairs, and Clinical/Post-Market teams to support resolution of product quality issues.
- ✓Support design verification and validation quality activities through review of documentation and participation in related quality processes.
- ✓Ensure product quality activities are performed in compliance with applicable regulatory requirements, quality system standards, and internal procedures.
- ✓Maintain clear, accurate, and timely documentation of investigations, analyses, and quality records.
- ✓Contribute to continuous improvement initiatives related to product quality, field performance, and quality system effectiveness.
Required/Preferred Education and Experience
- ✓Bachelor's Degree in Engineering or a related technical discipline.
- ✓2+ years of experience in quality engineering, product quality, or product engineering, preferably in a regulated industry.
- ✓Internship, co-op, or early career experience in medical devices, manufacturing, or a regulated industry.
- ✓Experience using quality system tools or data analysis tools is a plus.
Requirements
- ✓Hybrid/Remote role with occasional travel as needed for team meetings, training, investigations, audits, or site support
Physical Demands
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
- ✓Standing - Occasionally
- ✓Walking - Occasionally
- ✓Sitting - Constantly
- ✓Talking - Occasionally
- ✓Hearing - Occasionally
- ✓Repetitive Motions - Frequently
ZOLL is a fast-growing company that operates in more than 140 countries around the world. Our employees are inspired by a commitment to make a difference in patients' lives, and our culture values innovation, self-motivation and an entrepreneurial spirit. Join us in our efforts to improve outcomes for underserved patients suffering from critical cardiopulmonary conditions and help save more lives.
qualifications
of the successful candidate. Details of ZOLL's comprehensive benefits plans can be found at www.zollbenefits.com .
Applications will be accepted on an ongoing basis until this position is filled. For fully remote positions, c
Show full description ↓Show less ↑
Acute Care Technology At ZOLL, we're passionate about improving patient outcomes and helping save lives. We provide innovative technologies that make a meaningful difference in people's lives. Our medical devices, software and related services are used worldwide to diagnose and treat patients suffering from serious cardiopulmonary and respiratory conditions.
The Acute Care Technology division of ZOLL Medical Corporation develops and delivers innovative lifesaving products and software solutions to EMS, hospital, public safety, and military customers globally. Products include AEDs, trauma kits, ventilators, temperature management solutions, and more. Our dedicated employees take pride in their commitment to improving patient outcomes while delivering world-class customer service.
At ZOLL, you won't just have a job. You'll have a career—and a purpose.
Join our team. It's a great time to be a part of ZOLL!
Job Type
Hybrid
Due to the on‑site (hybrid)
Knowledge, Skills and Abilities
- •Basic understanding of engineering principles, data analysis, and problem-solving techniques.
- •Strong organizational skills and attention to detail, with the ability to manage documentation and follow established processes.
- •Ability to work collaboratively in a cross-functional team environment.
- •Strong written and verbal communication skills, with the ability to clearly document findings and communicate with technical stakeholders.
- •Ability to work effectively in a remote environment while collaborating across teams and time zones.
- •Familiarity with complaint handling, CAPA, nonconformance systems, or risk management processes.
- •Exposure to medical device design controls, verification and validation, or post-market quality activities.
- •Knowledge of FDA Quality System requirements, ISO 13485, or ISO 14971 is a plus
Preferred Languages
- +English - Advanced
Travel
The annual salary for this position is
$82,400.00 to $90,000.00
Factors which may affect starting salary include geography, skills, education, experience, and other