Top 330 quality manager Jobs in woburn ma

Quality Manager
Portal Instruments —Cambridge, MA
- $110,000 - $150,000 a year
- Email
- Hybrid work
- 7 years
- Management
- Engineering
- Commuter assistance
- Health savings account
Quick Apply
Lead Vascular Sonographer Quality/IAC Technical Lead - $7,500 Sign-on Bonus!
South Shore Health —Weymouth, MA
- $47.72 - $64.23 an hour
- Full-time
- Anatomy knowledge
- Hospital
- Senior level
Quality Manager for CNC Machine Shop (Watertown, MA)
Confidential-Manufacturing —Watertown, MA
- $90,000 - $130,000 a year
- Full-time
- Management
- Engineering
- Windows
- Profit sharing
- Health insurance
Quick Apply
2d
Director of Compliance, Quality & Risk- Home Care & Hospice
Care at Home —Lowell, MA
- $134,525.66 - $171,524.44 a year
- Full-time
- Nursing
- Microsoft Excel
- Ability to walk for extended periods
- Work from home
5d
Associate Director, Clinical Quality Assurance
BioNTech AG —Cambridge, MA
- $163,000 - $200,000 a year
- Full-time
- Background check
- 5 years
- Mentoring
- Health savings account
- AD&D insurance
Quality Manager - Manufacturing
Hoerbiger —Marlborough, MA
- $95,000 - $130,000 a year
- Full-time
- Hybrid work
- 5 years
- Engineering
- Organizational skills
- Disability insurance
- Health insurance
Quality Control Manager
The Middlesex Corporation —Boston, MA
- Full-time
- Bachelor's degree
- Experience equivalent to degree accepted
- In-person
- Health insurance
- Dental insurance
Quick Apply
CMM / Metrology Supervisor – Manufacturing Floor Quality Supervisor
Advanced Precision Engineering, Inc. —Ipswich, MA
- $30 - $50 an hour
- Full-time
- Supervising experience
- Mentoring
- In-person
Quick Apply
9d
RN Clinical Manager/QA Nurse - HYBRID Role!
MARY ANN MORSE HEALTHCARE CORP —Framingham, MA
- $80,000 - $95,000 a year
- Full-time
- Hybrid work
- Nursing
- RN License
- Mid-level
- Paid holidays
- Health insurance
Quick Apply
8d
Regional Lead Quality Engineer
CSL Behring —Waltham, MA
- $143,000 - $169,000 a year
- Full-time
- Team management
- Travel
- Organizational skills
Lead Vascular Sonographer Quality/IAC Technical Lead - $7,500 Sign-on Bonus!
South Shore Health —Weymouth, MA
- Full-time
- Anatomy knowledge
- Hospital
- Senior level
Quick Apply
5d
Principal Configuration Analyst - PCA Lead
Raytheon —Andover, MA
- $86,800 - $165,200 a year
- Full-time
- 3 years
- Bachelor's degree
- Product management
- Paid holidays
- Disability insurance
6d
Lead Quality Engineer
GE Aerospace —Lynn, MA
- Full-time
- Pass drug screening
- Mid-level
- 3 years
- Paid parental leave
- Disability insurance
4d
Quality Control Supervisor
Express Employment Professionals —Hyde Park, MA
- From $28 an hour
- Weekends as needed
- Spanish
- Mid-level
- Travel
- Health insurance
- Paid time off
Quick Apply
Manager, Food Safety & Quality Assurance
Home Market Foods —Norwood, MA
- $114,400 - $137,700 a year
- Weekends as needed
- Spanish
- Culinary experience
- Mid-level
- Relocation assistance
- Health insurance
Quick Apply
Lead QE Engineer /Lead Quality Engineer- Boston - RTH-70% hands-on and 30% leadership- Cloud and AI exp
Yoh, A Day & Zimmermann Company —Boston, MA
- $49.11 - $70.15 an hour
- Contract
- Hybrid work
- Computer science
- Computer Science
- Office
- Health savings account
- Disability insurance
Quick Apply
Team Quality & Safety Lead
Sealed Air —Ayer, MA
- $27 - $34 an hour
- Online Application
- Computer literacy
- Basic math
- Mid-level
- Disability insurance
- Health insurance
Manager Quality Control
TransMedics, Inc. —Andover, MA
- $118,600 - $148,000 a year
- Full-time
- 5 years
- Bachelor of Science
- Engineering
- Employee stock purchase plan
- Disability insurance
Quick Apply
QA Manager- Finished Goods Commercial
Vertex Pharmaceuticals —Boston, MA
- $118,400 - $177,600 a year
- Full-time
- Hybrid work
- Bachelor's degree
- Product management
- Conflict management
- Loan repayment program
- Health insurance
10d
Senior Manager, GMP Inspection Readiness
Vertex Pharmaceuticals —Boston, MA
- $127,000 - $190,400 a year
- Full-time
- Hybrid work
- 3 years
- Master's degree
- Analysis skills
- Loan repayment program
- Health insurance

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Quality Manager

Portal Instruments -
Cambridge, MA

Quick Apply

Job Details

Full-time
$110,000 - $150,000 a year

Benefits

Commuter assistance
Stock options
Health savings account
AD&D insurance
Disability insurance
Health insurance
Dental insurance
401(k)
Flexible spending account
Happy hour
Military leave
Paid time off
Parental leave
Employee assistance program
Vision insurance
401(k) matching
Employee discount
Life insurance
Retirement plan

Qualifications

Teamwork
Management
Preventive action implementation
Corrective and preventive actions (CAPA)
Quality management
Quality control audit
Quality assurance
Continuous improvement
Quality improvement
Compliance documentation
Regulatory readiness in healthcare
Design controls
Biomedical regulatory compliance
Training & development
ISO 13485
Cross-functional communication
FDA regulations
Audit support

Full Job Description

About Portal Instruments

Portal Instruments is redefining how advanced injectable therapies are delivered.

Founded on MIT research, we are building a next-generation drug delivery platform that enables high-volume, high-viscosity biologics to move from IV infusion to subcutaneous injection, unlocking a new generation of at-home therapies.

Our lead platform, PRIME Nexus™, combines reusable hardware with software-tunable delivery to enable therapies that were previously not feasible outside the clinic.

We have secured development partnerships with leading biotech companies and are now entering the most critical phase of the company: scaling from advanced engineering to clinical-ready and manufacturable systems.Role Information

Title: Quality Manager
Reports to: VP, Quality & Regulatory Affairs
Location: Hybrid (Primary location: Boston/Cambridge, MA)

Position Overview

Reporting to the VP, Quality & Regulatory Affairs, the Quality Manager will be a hands-on operational leader of Portal’s Quality Management System as we advance PRIME Nexus®, our reusable electromechanical drug delivery platform, through development, verification & validation, clinical use, and commercial launch. You will own and run core QMS processes day-to-day, partnering closely with engineering, software, manufacturing, supplier quality, and clinical teams to keep the program audit-ready and moving.

This is an opportunity to take ownership of how quality actually runs at Portal — to drive practical, compliant, and efficient processes that directly enable a novel drug delivery platform to reach patients.

What You’ll Do

Your Impact

· Keep Portal’s QMS running cleanly and audit-ready across CAPA, document control, change control, training, and supplier quality

· Partner cross-functionally with engineering, software, manufacturing, and clinical teams to translate quality requirements into practical, executable solutions

· Coach and elevate the broader organization on design controls, risk management, and good documentation practices

Key Responsibilities

· Own and execute core QMS processes day-to-day, including document control, change control, training, CAPA, nonconformance, internal audits, and management review preparation

· Lead design control activities for the electromechanical drug delivery device, including DHF maintenance, design reviews, traceability, and verification & validation documentation

· Drive risk management activities (ISO 14971), including hazard analysis, dFMEA/pFMEA/uFMEA, risk-benefit analysis, and risk file maintenance throughout the product lifecycle

· Manage complaint handling and post-market surveillance, including intake, investigation, MDR/vigilance evaluation, trending, and reporting

· Plan and conduct internal audits and supplier audits; manage supplier qualification, quality agreements, and supplier corrective actions in partnership with operations

· Support FDA inspections, notified body audits, and partner audits, including preparation, hosting, real-time response, and follow-up actions

· Partner with software and systems engineering on IEC 62304 software lifecycle activities, cybersecurity documentation, and software validation

· Support human factors and usability engineering activities, ensuring documentation aligns with IEC 62366 and FDA HFE expectations for at-home use

· Drive continuous improvement of QMS workflows, templates, and electronic systems (eQMS) so that processes remain compliant, lean, and easy to follow

· Develop and deliver QMS, design controls, and risk management training for the broader Portal team

· Maintain and report quality metrics and KPIs to support management review and leadership decision-making

What We’re Looking For

Required Qualifications

· Bachelor’s degree in engineering, physical sciences, or life sciences

· 7+ years of quality experience in medical devices, with at least 2 years in a quality lead or manager role

· Strong working knowledge of FDA 21 CFR Part 820, ISO 13485, and ISO 14971; familiarity with EU MDR

· Hands-on experience with design controls for electromechanical or software-containing medical devices

· Experience operating CAPA, complaint handling, document control, and internal audit programs

· Experience supporting FDA inspections, notified body audits, or external partner/customer audits

· Strong communication, organizational, and cross-functional collaboration skills, with the ability to operate in a fast-paced, evolving environment

Preferred Qualifications

· Experience with drug-device combination products and 21 CFR Part 4

· Experience with reusable medical devices, including reprocessing/cleaning validation

· Familiarity with IEC 62304 (software lifecycle), IEC 60601-1, IEC 62366 (usability), and ISO 10993 (biocompatibility)

· Experience implementing or administering an electronic QMS (e.g., Greenlight Guru, MasterControl, Veeva)

· ASQ CQA, CQE, or CMDA certification, or equivalent

· Experience working in a venture-backed or growth-stage medical device company

Working at Portal Instruments

Portal offers the opportunity to work on meaningful technology with real patient impact, alongside a highly collaborative and mission‑driven team. We value innovation, accountability, transparency, and thoughtful problem‑solving—and we believe great work happens when people feel supported and empowered.

Compensation

Salary Range (Massachusetts):

The expected base salary range for this role in Massachusetts is $110,000–$150,000, subject to confirmation with HR based on market benchmarking and internal equity.

Compensation for candidates in other U.S. locations may vary based on geographic market factors.
This role may also be eligible for additional compensation and benefits.

Benefits & Perks

Health & Wellness

· Medical plan options including PPO HSA and HMO HSA eligible plans

· Competitive dental, orthodontic, vision, and accident insurance

· Flexible Spending Accounts (medical, dependent care, commuter)

· Employee Assistance Program with counseling, financial tools, and legal resources

Financial & Protection

· Stock options

· 401(k) with Roth and traditional options

· 100% company-paid short- and long-term disability

· Company paid life and AD&D insurance

· Paid Family and Medical Leave

Rest & Recharge

· 20 days of vacation annually (encouraged to use)

· 13 company observed holidays

· Periodic company-wide holiday shutdowns

· Sick time separate from vacation

Additional Perks

· Daily lunch (Cambridge office)

· Casual dress code

· On site bike room, lockers, and showers (subject to availability)

· Happy hours and company sponsored events

· Annual volunteer opportunities and donation match program

Inclusion & Equal Opportunity

At Portal, we believe all employees should feel they belong, contribute, and thrive. We know that diverse teams create better solutions for diverse patients, and we encourage applicants from all backgrounds to apply.

Portal Instruments is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, ethnicity or national origin, sexual orientation, gender identity or expression, genetics, military service, age, family status, or disability.

How to Apply

Please submit a resume (and cover letter if applicable) to [email protected]. Candidates will be contacted if their background aligns with Portal's needs.

Pay: $110,000.00 - $150,000.00 per year

Benefits:

401(k)
401(k) matching
Dental insurance
Employee assistance program
Employee discount
Flexible spending account
Health insurance
Health savings account
Life insurance
Military leave
Paid time off
Parental leave
Retirement plan
Vision insurance

Application Question(s):

Will you now or in the future require employer sponsorship for a work visa?

Experience:

Quality assurance: 7 years (Required)

Work Location: In person

Quick Apply

Refine Your Search

quality manager jobs in woburn ma

Quality Manager

Lead Vascular Sonographer Quality/IAC Technical Lead - $7,500 Sign-on Bonus!

Quality Manager for CNC Machine Shop (Watertown, MA)

Director of Compliance, Quality & Risk- Home Care & Hospice

Associate Director, Clinical Quality Assurance

Quality Manager - Manufacturing

Quality Control Manager

CMM / Metrology Supervisor – Manufacturing Floor Quality Supervisor

RN Clinical Manager/QA Nurse - HYBRID Role!

Regional Lead Quality Engineer

Lead Vascular Sonographer Quality/IAC Technical Lead - $7,500 Sign-on Bonus!

Principal Configuration Analyst - PCA Lead

Lead Quality Engineer

Quality Control Supervisor

Manager, Food Safety & Quality Assurance

Lead QE Engineer /Lead Quality Engineer- Boston - RTH-70% hands-on and 30% leadership- Cloud and AI exp

Team Quality & Safety Lead

Manager Quality Control

QA Manager- Finished Goods Commercial

Senior Manager, GMP Inspection Readiness

I want to receive the latest job alert for quality manager in woburn ma

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