Top 436 Quality engineer Jobs in Billerica Ma

Quality Engineer
American Surgical Company —Beverly, MA
- $110,000 - $130,000 a year
- Full-time
- Microsoft Excel
- 3 years
- Analysis skills
- Profit sharing
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Software Design Quality Engineer
Philips —Bedford, MA
- $102,480 - $163,968 a year
- Full-time
- Computer Science
- 5 years
- Travel
- Health savings account
- Employee stock purchase plan
Senior Engineer, Quality Engineering
Entegris, Inc —Bedford, MA
- $91,000 - $114,000 a year
- Full-time
- 5 years
- Bachelor of Science
- Continuous improvement
- Paid holidays
- Health insurance
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Contract QA Engineer - AI Trainer
DataAnnotation —North Andover, MA
- $50 - $100 an hour
- Part-time
- Remote
- Writing skills
- English
- Mid-level
- Flexible schedule
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Medical Devices Design Assurance Engineer
Motion Recruitment —Marlborough, MA
- Full-time
- Microsoft Word
- Mid-level
- 3 years
- Health savings account
- Employee stock purchase plan
Quality Engineer
LAB Medical Manufacturing —Billerica, MA
- Bachelor of Science
- Mid-level
- 3 years
- Health insurance
- Dental insurance
Quality Engineer I
Integer Holdings Corporation —Hudson, MA
- $64,350 - $93,170 a year
- Full-time
- Military encouraged
- Organizational skills
- Entry level
- Disability insurance
- Health insurance
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Quality Engineer- New Product Development
SMC Ltd. —Devens, MA
- $100,000 - $130,000 a year
- Full-time
- Microsoft Word
- Background check
- Computer literacy
- Paid holidays
- Disability insurance
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Product Safety Quality Engineer
Philips —Cambridge, MA
- $92,000 - $163,000 a year
- Full-time
- Mid-level
- Office
- Master's degree
- Health savings account
- Employee stock purchase plan
2d
Quality Engineer - Manufacturing
A.W. Chesterton Company —Groveland, MA
- $85,000 - $90,000 a year
- Full-time
- Background check
- Engineering
- Mid-level
- Health savings account
- Paid holidays
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Senior QA Engineer
Verve Inc —Cambridge, MA
- $110,000 - $150,000 a year
- Full-time
- Java
- 8 years
- Software development
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Quality Engineer II
Pramand LLC —Bedford, MA
- $77,000 - $100,000 a year
- Full-time
- Computer literacy
- Engineering
- Laboratory experience
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Supplier Quality Engineer 2
Teleflex —Chelmsford, MA
- $87,400 - $131,100 a year
- Mid-level
- Travel
- SharePoint
- Disability insurance
- Health insurance
23h
Quality Engineer
American Flowform & Machining —Billerica, MA
- $80,000 - $100,000 a year
- Weekends as needed
- Microsoft Excel
- Microsoft Outlook
- Engineering
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Quality Engineer II
Anika Therapeutics —Bedford, MA
- $84,000 - $105,000 a year
- Full-time
- Writing skills
- Engineering
- Mid-level
- Health savings account
- Employee stock purchase plan
Quick Apply
Senior QA Engineer
Prenuvo —Boston, MA
- $140,000 - $153,000 a year
- Email
- Remote
- Background check
- Computer science
- Computer Science
- Commuter assistance
- Health insurance
Quick Apply
Senior Designs Assurance Quality Engineer
Access Vascular —Billerica, MA
- $135,000 - $160,000 a year
- 5 years
- Bachelor of Science
- Organizational skills
Quick Apply
Senior Quality Systems Engineer
Access Vascular —Billerica, MA
- $93,000 - $160,000 a year
- 5 years
- Engineering
- Mentoring
Quick Apply
Product Quality Engineer
ConforMIS, Inc. —Wilmington, MA
- Full-time
- Bachelor of Science
- Writing skills
- Engineering
Quality Assurance Engineer
BRUNT Workwear —Wilmington, MA
- $100,000 - $120,000 a year
- Weekends as needed
- 18 years or older
- Mid-level
- Office

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quality engineer jobs near billerica ma

Quality Engineer

American Surgical Company
Beverly, MA

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Job Details

Full-time
$110,000 - $130,000 a year

Benefits

Profit sharing

Qualifications

Teamwork
Compliance audits & assessments
Manufacturing facility experience
Attention to detail
Problem-solving

Full Job Description

American Surgical Company is seeking an experienced and results-driven Quality Engineer to join our Quality team. This hands-on role is responsible for developing, implementing, and sustaining quality systems and processes that ensure products and manufacturing operations comply with internal quality standards and external regulatory requirements, including ISO 13485 and FDA Quality System Regulations. The Quality Engineer will lead quality improvement initiatives, support risk management activities, drive investigations and corrective actions, and partner closely with Manufacturing, R&D, Regulatory Affairs, and Operations teams to ensure product quality, patient safety, and regulatory compliance.

The ideal candidate will possess strong analytical and problem-solving skills, experience working in a regulated manufacturing environment, and a proven track record of driving continuous improvement through data-driven quality engineering practices.

Essential Duties and Responsibilities:

Develop, implement, and maintain quality assurance and quality control processes, procedures, work instructions, and other controlled documentation in compliance with ISO 13485, FDA regulations, and internal quality system requirements.
Lead investigations into nonconformances, customer complaints, supplier quality issues, and manufacturing defects using structured root cause analysis methodologies.
Drive corrective and preventive actions (CAPA) to closure, ensuring effectiveness checks are completed and sustainable solutions are implemented.
Analyze quality data, including defect trends, process capability studies, yield metrics, complaint data, and audit findings to identify opportunities for continuous improvement.
Lead and support risk management activities, including DFMEA, PFMEA, hazard analysis, and risk mitigation strategies throughout the product lifecycle.
Support validation activities, including IQ/OQ/PQ, test method validations, and process validation studies to ensure compliance with regulatory and quality requirements.
Partner with Manufacturing Engineering and Production teams to improve process capability, reduce variability, and enhance product quality and operational efficiency.
Support new product introduction (NPI) and design transfer activities by ensuring quality requirements are incorporated into manufacturing processes and documentation.
Review engineering drawings, specifications, design documentation, and manufacturing processes to ensure compliance with applicable standards and customer requirements.
Develop and maintain inspection methods, sampling plans, test protocols, and measurement systems to support product acceptance and process monitoring.
Perform statistical analyses using quality tools and software to support process improvement, validation, and decision-making activities.
Support internal, supplier, customer, and regulatory audits, including preparation, participation, response development, and follow-up actions.
Collaborate with suppliers to resolve quality issues, conduct supplier evaluations, and support supplier qualification activities.
Lead or participate in change control activities, including evaluation of quality impacts associated with engineering changes, process changes, and material changes.
Monitor and report key quality metrics, including nonconformances, CAPA effectiveness, complaint trends, audit findings, and process performance indicators.
Prepare technical reports, presentations, and quality documentation to communicate findings, recommendations, and project status to stakeholders.
Provide training and guidance to personnel on quality system requirements, quality tools, and best practices.

Skills:

Strong analytical and problem-solving abilities with a data-driven approach.
Strong understanding of quality engineering principles and methodologies, including: o CAPA (Corrective and Preventive Actions)

o FMEA (Failure Mode and Effects Analysis)

o SPC (Statistical Process Control)

o MSA (Measurement System Analysis)

o Root Cause Analysis

o Risk Management (ISO 14971)

Experience with process validation, test method validation, and equipment qualification activities.
Familiarity with ISO 13485, FDA Quality System Regulations (21 CFR Part 820/QMSR), and other applicable regulatory requirements.
Experience with UDI/GUDID compliance and labeling change control activities is a plus.
Familiarity with product technical files and manufacturing/batch records in a regulated environment is a plus.
Proficiency with statistical analysis tools such as Minitab.
Strong technical writing skills with the ability to develop and maintain compliant quality documentation.
Proficiency in Microsoft Office Suite (Excel, Word, PowerPoint).
Strong organizational and project management skills with the ability to manage multiple priorities.
Effective communication and collaboration skills across cross-functional teams.
Ability to work independently while providing leadership on quality initiatives.
Comfortable working in a manufacturing environment, including Class 8 Cleanroom operations.
Detail-oriented with a commitment to product quality, compliance, and continuous improvement.

Education and Experience:

Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, Manufacturing Engineering, Quality Engineering, Industrial Engineering, Materials Engineering, or a related technical discipline.
3–7 years of experience in a manufacturing or regulated operations environment, preferably within the medical device industry.
Experience supporting quality systems compliant with ISO 13485 and FDA regulations.
Hands-on experience with CAPA, nonconformance investigations, root cause analysis, and quality improvement initiatives.
Experience with risk management activities, including FMEA and risk assessments.
Experience supporting process validations (IQ/OQ/PQ), test method validations, and change control processes.
Experience supporting new product introductions, design transfer activities, or product lifecycle management is strongly preferred.
Knowledge of Lean Manufacturing and Six Sigma methodologies; certification is a plus.
Experience participating in internal, supplier, customer, or regulatory audits is preferred.
ASQ Certified Quality Engineer (CQE) certification is a plus.

Language Skills:

Must be fluent in English, with the ability to read, write, and communicate technical information clearly and effectively in both verbal and written formats.

Proficiency in Spanish is a plus and may be beneficial for effective communication in a diverse manufacturing environment.

Compensation & Benefits

American Surgical Company offers a competitive compensation and benefits package, including eligibility to participate in the Company's Profit Sharing Program in accordance with plan provisions and eligibility requirements.

Schedule: Monday-Friday (8:00 AM - 4:30 PM)

This role is not eligible for visa sponsorship at this time.

Pay: $110,000.00 - $130,000.00 per year

Work Location: In person

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Refine Your Search

quality engineer jobs in billerica ma

Quality Engineer

Software Design Quality Engineer

Senior Engineer, Quality Engineering

Contract QA Engineer - AI Trainer

Medical Devices Design Assurance Engineer

Quality Engineer

Quality Engineer I

Quality Engineer- New Product Development

Product Safety Quality Engineer

Quality Engineer - Manufacturing

Senior QA Engineer

Quality Engineer II

Supplier Quality Engineer 2

Quality Engineer

Quality Engineer II

Senior QA Engineer

Senior Designs Assurance Quality Engineer

Senior Quality Systems Engineer

Product Quality Engineer

Quality Assurance Engineer

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