New · posted Oct 15
Access Vascular · Medical Devices
Senior/Principal Quality Systems Engineer
- Billerica, MA
- On-site
- Full-time
- Senior & Principal
Open until filled
The role
Access Vascular designs, manufactures, and distributes sterile catheter-based, software-enabled, and electromechanical medical devices. This role helps oversee our Quality Management System and provides Quality Engineering support across Operations, working closely with a small, hands-on team under AVI's QMS and FDA QMSR requirements.
Quality Management System
- Help maintain and continuously improve our QMSR and ISO 13485-compliant QMS
- Support improvements to SOPs, work instructions, forms, test protocols, and other controlled documents
- Support document control and records management under 21 CFR Part 820
- Participate in internal audits and support external audits (FDA, supplier)
- Lead or support CAPA investigations — root cause analysis, timely closure, effectiveness verification
- Help develop quality metrics and data analysis to guide risk-based decisions
Operations & Supplier Quality
- Partner with Operations to help ensure manufacturing processes are controlled and validated
- Contribute to risk management, sterilization validation, and data integrity practices
- Support incoming inspection, nonconforming material control, and disposition
- Provide Quality Engineering input on infrastructure and expansion projects
- Support supplier qualification, evaluation, and monitoring
- Help conduct supplier audits and review corrective action responses
Post-Market Surveillance
- Support complaint handling, MDR reporting, and trend analysis
- Stay current on relevant standards and regulations and help keep the team informed
- Assist with preparation for FDA inspections and Notified Body audits
What you need
- Bachelor's degree in Engineering, Life Sciences, or a related technical field
- Minimum of 5 years’ of quality systems experience with a medical device manufacturing company
- Proven track record with implementing, evolving, and improving medical device company quality management systems (QMS) compliant to FDA 21 CFR Part 820, ISO 13485:2016, and ISO 14971
- Demonstrated experience owning a QMS end-to-end, including CAPA, document control, complaints, internal auditing, and supplier quality
- Strong technical writing skills with the ability to produce clear, compliant documentation
- Experience with statistical techniques, sampling plans, and data analysis for validation and process capability
Compensation Commensurate With Experience
$93,000—$160,000 USD
Pay
$93,000 – $160,000 a year
Employer providedWhere you'll work
Billerica, MAOn-siteOpen in Maps (opens in a new tab)
More jobs in Billerica, MAFrom the posting
About Access Vascular
Leadership & Culture
- Help champion a proactive quality culture across a small, multidisciplinary team
- Offer quality training and mentoring where you can — we all wear a few hats here!
Access Vascular was founded in 2015 to address the most common and costly complications of intravenous therapy: infection, thrombosis and phlebitis. The company is developing a suite of venous access devices made from patented biomaterials which are highly biocompatible and have demonstrated 6X fewer complications. .
Job intelligence
The context around this role
Live data · October 15, 2026
Salary intelligence
How the pay compares
This role's midpoint is 3% above the US median for Quality Assurance roles at this level.
This roleEmployer provided
Senior & Principal roles in Massachusetts25 roles publishing pay
Senior & Principal roles in the US284 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $93,000 | — | $160,000 |
| Massachusetts (middle half) | $108,500 | $125,000 | $133,000 |
| All US (middle half) | $103,375 | $122,750 | $137,500 |
This role: Access Vascular's own published range. Comparisons: the base pay employers published on open Quality Assurance roles at the same level on Regulatory Jobs, October 15, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Quality Assurance
The general path across 845 open Quality Assurance roles on Regulatory Jobs, with the titles they carry most. Not Access Vascular's own promotion track.
Career resources on Quality Assurance
Skills DNA
What this role leans on
How many of the posting's 24 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Quality systems and risk10
- GMP and compliance8
- Documentation and SOPs5
- Investigations and CAPA4
- Validation and qualification4
- Collaboration and leadership3
- Data and digital systems2
- Lab testing and methods1
- Regulatory submissions1
Regulatory intelligence
The rules behind this role
Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.
- FDA21 CFR Part 820 (QMSR)(official source, opens in a new tab)FDA quality management system regulation for medical devices
- FDAFDA data integrity guidance(official source, opens in a new tab)Data Integrity and Compliance With Drug CGMP: Questions and Answers
- ISOISO 13485(official source, opens in a new tab)Quality management systems for medical devices
- ISOISO 14971(official source, opens in a new tab)Risk management for medical devices
Company hiring pulse
Access Vascular on Regulatory Jobs
- 1
- Open roles
- 1
- Distinct roles
- 1
- Locations
Similar Quality Assurance roles elsewhere
- View role
Senior Supplier Quality Engineer
iRhythmOrange County, CA · HybridSenior & PrincipalMedical Devices$99K–$129K
- View role
Senior Design Quality Engineer
iRhythmSan Francisco, CA +1 more · HybridSenior & PrincipalMedical Devices$138K–$180K
- View role
Senior Supplier Quality Engineer
The Cooper CompaniesTrumbull, CT +1 more · HybridSenior & PrincipalMedical Devices$100K–$125K
- View role
Quality Management Systems Specialist
The Cooper CompaniesVictor, NYSenior & PrincipalMedical Devices$58K–$78K
Senior/Principal Quality Systems Engineer at Access Vascular
Open until filled. $93K–$160K a year, employer provided.