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,…
Skills: Process validation, Supplier quality, IQ/OQ/PQ, Data analytics, Continuous improvement
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$109k–$150k/yr
Full-time
bachelor degree, postgraduate degree
Medical, Dental, Vision, Life insurance, Short-term disability, Long-term disability
Posted 20d ago
~40 hrs/week
Responsibilities
The Staff Quality Engineer will lead supplier process validation activities, including IQ/OQ/PQ, to ensure compliance with medical device standards. They will also drive continuous improvement initiatives and manage supplier quality issues through data-driven decision-making and audits.
Requirements
Candidates must have a bachelor's degree with at least 10 years of experience in engineering or quality, specifically within the medical device or pharmaceutical industry. Strong expertise in process validation, regulatory standards like ISO 13485, and data analytics is required.
Full 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.
Job Description
This position is for a Staff Engineer - Supplier Quality Validation Engineer with hands-on experience and proven success in Process Validation and driving cont. improvement with suppliers. This position will be primarily engaged to ensure timely completion of process validation requirements of new products and life cycle change management (LCM) projects with suppliers to the required quality standard in accordance with defined program and company requirements. The ideal candidate should demonstrate proficient experience with quality management concepts, IQ/OQ/PQ process validation and manufacturing engineering to drive continuous improvement. The candidate will act as liaison between the organization and the supplier to lead and communicate the component/process validation requirements and ensure timely completion and verification of the activities.
RESPONSIBILITIES
Responsible for communication, verification and execution of process validations of supplier processes that involve products procured and used by Integra for the Integra Codman Specialty Surgical and Tissue Technologies divisions.
Ensure supplier Process validation requirements (CTQs, drawings, specifications, FAIs etc.) and protocol for IQ/OQ/PQ are communicated, completed, and verified for each responsible group.
Drive continuous improvement in supplier quality processes through data analysis and identification of areas for improvement.
Perform for-cause audits to determine root cause and drive CAPAs while supporting the site supplier quality teams.
Provide support to sites by leading critical Supplier Quality related issues which may require supplier visits and audits.
Review and approve executed qualification documentation (IQ/OQ/PQ) with suppliers for new product and LCM projects.
Develop and promote the right behaviors to sustain a culture of continuous improvement necessary to support both short- and long-term business objectives.
Support the supplier consolidation initiative.
Provide and develop training on the Process Validation concepts to the team and organization, as needed.
Utilize coaching and facilitating skills with program shareholders to ensure proper project management, expectation setting, and best practices are utilized.
Direct the activities of the GSQ department to ensure compliance with all appropriate regulations and standards, including FDA, ISO 13485, CMDR, MDR, 21 CFR Part 11 & IQ/OQ/PQ.
Interact and coordinate activities with other departments, external vendors, and customers. Influences and collaborates across stakeholder groups in the areas of process / continuous improvements, identify and implement opportunities.
QUALIFICATIONS
Bachelor's degree or equivalent with 10+ years of experience, master's degree with 8+ years of experience, Doctoral degree with 5+ years of experience in manufacturing engineering, Mechanical Engineering, Industrial Engineering, Quality or relevant engineering degree.
Fluent in English with strong communication skills
Strong experience in process validation and component qualification - IQ/OQ/PQ and data analytics
Medical Device or Pharmaceutical experience is required.
Experience or knowledge of ISO 9001 and ISO 13485 requirements preferred.
Travel up to 10% with a possibility of international travel.
Experience in FDA and other regulatory controlled environment.
Strong collaboration skills and experience working in a matrix environment.
Ability to read and understand technical and statistical documents.
Ability to interface with technical and non-technical personnel.
Knowledge of current Good Manufacturing Practices (cGMP) and other applicable standards.
Experience using analytical tools to drive data-based decision making.
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)).
Subject to the terms of their respective policies and date of hire, Employees are eligible for the following Total Rewards | Integra LifeSciences
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 careers@integralife.com.
Unsolicited Agency Submission
Integra LifeSciences does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. A formal written agreement is required before engaging any agency, and it must be executed and authorized by the Vice President, Talent Acquisition. Where agency agreements are in place, introductions (the initial sharing of a candidate’s name, resume, or background) are position-specific and may only occur within the scope of that approved agreement. Please, no phone calls or emails.
Integra LifeSciences is a global medical technology leader dedicated to restoring lives. Headquartered in Princeton, New Jersey, we are advancing transformational care through impactful innovation in neurosurgery and tissue reconstruction, specialized fields that demand exceptional expertise and precision. Our portfolio of highly differentiated gold-standard products and solutions is built on decades of clinical evidence and trusted by healthcare professionals to improve patient outcomes.
For the latest news and information about Integra and our products, visit www.integralife.com.
Offices: 1100 Campus Road, Princeton, New Jersey 08540, US
How much do Data & Analytics jobs in Princeton, NJ pay?
Based on 184 listings with disclosed salaries, most data & analytics jobs in Princeton, NJ pay between $95k–$224k per year. Individual offers vary with seniority, company size, and specialization.
How many Data & Analytics jobs are open in Princeton, NJ right now?
There are currently 202 open data & analytics positions in Princeton, NJ listed on Clera. New openings are added daily as companies post roles.
Which companies are hiring for Data & Analytics roles in Princeton, NJ?
Companies currently hiring include Bristol Myers Squibb, Otsuka Pharmaceutical Companies (U.S.), State Street, Integra LifeSciences, Munich Re, among others. Browse the listings above to see every active employer.
Are there remote or hybrid Data & Analytics jobs in Princeton, NJ?
Yes — 142 of the 202 open data & analytics positions offer remote or hybrid work (8 remote, 134 hybrid).
How do I apply for Data & Analytics jobs in Princeton, NJ?
Each listing links directly to the employer's application page. Apply early — fresh listings get the most recruiter attention in the first two weeks.