Manager, Quality Engineering

INTEGRA LIFESCIENCES CORP; Plainsboro Township (NJ); On-site; USD 109,000 - 150,000; Full time

Job summary

Integra LifeSciences seeks a Manager, Quality Engineering in Plainsboro, NJ to lead a team providing GMP‑compliant quality engineering support across manufacturing, development and validation projects. You will drive CAPAs, risk assessments, and investigations, mentor engineers, and partner with QA, Regulatory and Operations to ensure product quality, regulatory readiness and continuous improvement.

You will build a strong team, mentor engineers, and partner with QA, Regulatory and Operations to

Qualifications

• BS degree in Engineering or Science; ASQ/CQE preferred.
• 7–10 years in quality assurance/engineering in manufacturing.
• Strong written and verbal communication.
• Knowledge of FDA GMPs, ISO 9001/14971/13485; medical device exp preferred.
• Ability to think strategically and lead cross-functional teams.

Responsibilities

• Maintain understanding of applicable requirements and standards (FDA GMPs, ISO 9001, ISO 14971, ISO 13485, MDSAP).
• Lead Quality Engineering support for Manufacturing, QA/QC, Regulatory Compliance, Product Development, and other partners.
• Build and develop a strong team of quality engineers through hiring, onboarding, coaching, and resource planning.
• Develop and implement new processes, transfers, and continuous improvement activities.
• Provide guidance on verification/validation plans, process validation, test methods, and sterilization validation.
• Lead or support investigations involving product, process, equipment, and validation.
• Provide QA partnership for nonconformances and customer complaint investigations with RCA and CAPAs.
• Ensure deliverables are complete, accurate, and documented within timelines.
• Lead risk-management activities and analyze data to identify improvement opportunities.
• Participate in regulatory submissions, inspections, and audits.

Skills

Quality engineering

GMP knowledge

Regulatory knowledge

Leadership

Communication

Education

BS in Engineering or Science

ASQ/CQE certification

Tools

MS Office

Quality Management System

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.

SUMMARY DESCRIPTION

The Manager, Quality Engineering leads Quality Engineering support for manufacturing, product development, process improvement, validation, risk management, and technical issue resolution. The role ensures that products and processes are developed, validated, transferred, maintained, and improved in compliance with company procedures and applicable regulatory requirements. The Manager provides Quality Engineering partnership and technical expertise for nonconformances, CAPAs, customer complaints, and other cross-functional quality activities.

SUPERVISION RECEIVED

Under direct supervision of the Director, Quality Operations, with collaboration with site leadership to establish project objectives and priorities.

SUPERVISION EXERCISED

Works independently with minimal supervision and supervises a staff of quality engineers and support staff.

DISCRETION & LATITUDE

The Manager, Quality Engineering assesses technical and quality data, establishes engineering priorities, provides technical direction to staff, and escalates significant product, process, compliance, and business risks to management for review.

ESSENTIAL DUTIES AND RESPONSIBILITIES

• Maintain a thorough understanding of applicable requirements and standards, including FDA GMPs, ISO 9001, ISO 14971, ISO 13485, MDSAP company policies and procedures, validation guidance, and other applicable standards.
• Lead Quality Engineering support for Manufacturing, QA/QC, Regulatory Compliance, Product Development, and other business partners.
• Build and develop a strong team of quality engineers through effective hiring, onboarding, coaching, goal setting, retention, and resource planning.
• Participate in the development and implementation of new processes, process and product transfers, continuous improvement activities, and technical issue resolution.
• Provide guidance on verification and validation plans, process validation and revalidation, test methods, sampling methods and plans, test equipment acquisition, sterilization validation and revalidation, and Process Excellence initiatives.
• Lead or support technical investigations involving product, process, equipment, test method, validation, and manufacturing performance issues.
• Provide Quality Engineering partnership and technical expertise for nonconformances, CAPAs, and customer complaint investigations, including technical assessment, investigation support, risk evaluation, root-cause analysis, action development, and effectiveness evaluations, as applicable.
• Ensure Quality Engineering deliverables and assigned technical investigation activities are complete, accurate, scientifically sound, appropriately documented, and completed within established timelines.
• Lead and document product and process risk-management activities within the Quality Engineering scope, including risk assessments supporting investigations, process changes, validation, transfers, and issue resolution.
• Analyze engineering and manufacturing data, including process capability, statistical process control, validation results, recurring technical issues, and other relevant quality indicators, to identify opportunities for improvement and risk reduction.
• Participate in the compilation and review of technical documentation supporting domestic and international regulatory submissions, inspections, and audits.
• Participate in external and internal audits, including FDA, Notified Body, customer, and corporate audits, by providing Quality Engineering subject-matter expertise and objective evidence.
• Benchmark regulatory and industry practices and participate in professional forums or committees that influence engineering, validation, risk-management, and quality practices.
• Perform other related duties as necessary.

DESIRED MINIMUM QUALIFICATIONS

• Education: BS degree in Engineering or Science; ASQ/CQE certification strongly preferred.
• Experience: 7-10 years of quality assurance engineering, manufacturing engineering, validation, reliability, or related experience supporting manufacturing; product-development experience is a plus.
• Excellent written and verbal communication skills.
• Working knowledge of GMP, Quality Engineering, validation, risk management, and applicable Quality System requirements; medical-device industry experience strongly preferred.
• Demonstrated knowledge of FDA GMPs, ISO 9001, ISO 14971, ISO 13485, company policies and procedures, validation guidance, and other applicable standards.
• Demonstrated ability to think strategically, lead technical teams, manage priorities, and collaborate across functions.

TOOLS AND EQUIPMENT USED

Ability to use a computer, telephone, and general office equipment. Strong computer skills and familiarity with Microsoft Office applications are required.

Salary Pay Range

Salary Pay Range: $109,250.00 - $149,500.00 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.

Additional Description for Pay Transparency

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)).

EEO Statement

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 on your rights 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].

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.