Engineer II, Quality

Integra-Lifesciences; Braintree (MA); On-site; USD 71,000 - 98,000; Full time

Benefits offered by this job

Medical, dental, vision benefits

401(k) retirement plan

Paid time off

Job summary

Integra LifeSciences in Massachusetts is seeking a Quality Engineer II to independently support manufacturing and engineering operations. The role ensures safe, compliant medical devices by owning investigations, CAPAs, risk management, and validation activities within cGMP and regulatory frameworks.

The position emphasizes data-driven quality improvements, DOEs, MRB coordination, and cross‑functional collaboration to support NPI, transfers, and regulatory submissions. On-site work required.

Qualifications

• Bachelor's degree in Engineering or Life Science.
• Minimum 3 years of Quality Engineering in a regulated setting.
• Experience with FDA/ISO quality standards in medical devices.
• Experience owning nonconformances, investigations, and CAPAs.
• Knowledge of QMS, ERP, and data systems.

Responsibilities

• Own investigations, NCs, and CAPAs; perform root cause analysis and effectiveness checks.
• Lead or support validation activities for processes, tests, and equipment.
• Conduct or support audits and regulatory inspections (FDA/ISO).
• Develop DOEs and statistically sound tests to support results.
• Collaborate with Manufacturing, Engineering, Regulatory, and Supply Chain.

Skills

Quality Engineering

FDA QSR

CAPA management

Risk management

Statistical analysis

Minitab

ERP systems

SQA documentation

Education

Bachelor's degree in Engineering/Life Science

Tools

TrackWise

ERP systems

Minitab

Databases

Job description

Changing lives. Building Careers. Joining us is a chance to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, our colleagues are challenging what’s possible and making headway to innovate new treatment pathways to advance patient outcomes and set new standards of care.

Position Summary

The Quality Engineer II (QE II) is responsible for independently supporting manufacturing and engineering operations to ensure the manufacture of safe, compliant, and high‑quality medical devices. This role maintains and improves quality system effectiveness through ownership of investigations, CAPAs, risk management activities, and validation support, while ensuring compliance with applicable regulatory requirements and corporate policies. The QE II operates with general supervision and increased technical depth compared to entry‑level Quality Engineers.

Job Description

• Ensure compliance with cGMP, FDA QSR, ISO 13485, ISO 9001, MDR/CMDR (as applicable), and internal Quality Management System procedures
• Independently own and close investigations, nonconformances, and CAPAs of moderate complexity, including root cause analysis and effectiveness checks
• Assist or lead nonconforming product activities, including investigations and coordination/management of MRB review and approval
• Review and approve quality records within established authority, including deviations, change controls, validation documentation, and risk management records
• Lead or support process, test method, and equipment validation activities, including protocol execution and report approval
• Execute and lead pFMEA and risk management activities in support of manufacturing and process changes, including pFMEA developments and updates
• Provide quality engineering support to manufacturing operations, including disposition of nonconforming material and process issue resolution
• Support new product introductions (NPI) and transfer activities as the Quality Engineering representative
• Work with project teams to develop DOEs and statistically sound tests for appropriate support of results
• Apply statistical and risk‑based tools such as SPC, sampling plans, and data trending to identify and drive process improvements
• Participate in internal/external audits, supplier audits, and regulatory inspections (FDA, ISO), including preparation and response support
• Assist or lead customer complaint investigations and post‑market surveillance activities, as assigned
• Collaborate cross‑functionally with Manufacturing, Engineering, Regulatory Affairs, Supply Chain, and Operations
• Prepare quality data and metrics to support management review and continuous improvement initiatives
• Support corporate Regulatory Affairs by providing information for submissions and Annual Reports
• Identify and implement opportunities for continuous improvement

Position is based on‑site.

Required Qualifications

• Bachelor's degree in Engineering (Biomedical, Mechanical, Chemical, Electrical) or a Life Science discipline (Biology, Chemistry) or related technical field
• Minimum 3 years of Quality Engineering experience in a regulated manufacturing environment (or 1-2 years with a Master's degree)
• Medical device industry experience
• Experience applying FDA and ISO quality standards within a regulated medical device environment
• Experience in Quality Engineering, Quality Assurance, or Quality Compliance within a regulated industry
• Working knowledge of FDA Quality System Regulations (21 CFR 820), ISO 13485, ISO 9001, cGMP, and risk management principles (ISO 14971)
• Experience owning and managing nonconformances, investigations, CAPAs, and nonconforming product processes
• Experience supporting change control activities and process, test method, and equipment validations
• Ability to analyze process and quality data, identify trends, and recommend improvements
• Knowledge of statistical sampling and analysis; experience with SPC, Minitab, or equivalent statistical tools
• Proficiency with Quality Management Systems (QMS), ERP systems, databases, and Microsoft Office applications
• Ability to query databases and generate reports
• Strong technical aptitude, including the ability to read, interpret, and execute technical documentation and procedures
• Strong written and verbal communication skills
• Demonstrated ability to work effectively in cross‑functional team environments
• Ability to follow instructions precisely, identify deviations, and recommend corrective actions
• Commitment to following company policies and safety procedures

Preferred Qualifications

• Certified Quality Engineer (CQE) certification
• Experience with TrackWise Digital
• Cleanroom manufacturing experience
• Advanced experience supporting manufacturing operations through process monitoring, quality improvement initiatives, and technical problem‑solving

Salary

Salary Pay Range: $71,300.00 - $97,750.00 USD

Salary Our salary ranges are determined by role, level, and location. Individual pay is determined by several factors including job‑related skills, experience, and relevant education or training. In addition to base pay, employees may be eligible for bonus, commission, equity or other variable compensation. Your recruiter can share more about the specific salary range for your preferred location during the hiring process.

Benefits

• Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long‑term disability, business accident insurance, and group legal insurance, and savings plan (401(k)).
• Subject to the terms of their respective policies and date of hire, Employees are eligible for the following Total Rewards | Integra LifeSciences

Equal Opportunity Employer

Integra LifeSciences is an equal opportunity employer, and is committed to providing equal employment opportunities to all qualified applicants and employees regardless of race, marital status, color, religion, sex, age, national origin, sexual orientation, physical or mental disability, or protected veteran status. This site is governed solely by applicable U.S. laws and governmental regulations. If you'd like more information under the law, please see the following notices: EEO Is the Law | EOE including Disability/Protected Veterans. Integra LifeSciences is committed to provide qualified applicants and employees who are disabled veterans or individuals with disabilities with needed reasonable accommodations in accordance with the ADA. If you have difficulty using our online system due to a disability and need an accommodation, please email us at [e-mail].

Employer Branding

Whatever your specialty, you’ll find an ideal setting for building a rewarding career. Along the way, you’ll have the satisfaction of knowing your work matters, that it’s making patients’ lives better, making a positive and lasting difference. You’ll find that the pace is exhilarating – because the need is so urgent. You’ll be challenged – and supported – by the most dynamic and inspiring people in your profession. And you’ll grow a career that is more impactful and fulfilling then you thought possible. More than 4,200 Integra employees already know we’re a great place to build a career. Here’s your chance to discover that for yourself.