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
The Global Supplier Quality Engineer II will play a vital role supporting Supplier Quality by conducting supplier audits and maintain supplier quality requirements for Integra's manufacturing site in Plainsboro, NJ. This individual will provide quality assurance leadership to select contract manufacturing sites and raw material suppliers engaged in the production of Integra products.
This is a hybrid position which will require you to be onsite at least 3 days per week in Plainsboro, NJ.
JOB DESCRIPTION
Establishes and ensures the Approved Supplier List is up to date
Establishes timely planning and execution of supplier audits
Conducts Supplier Audits according to good manufacturing practices, ISO Standards, and applicable regulatory requirements
Ensures comprehensive measurement systems in place to monitor supplier quality/reliability, and to identify, correct and prevent defects
Establish and ensure Supplier Quality Agreements are up to date for applicable suppliers engaged in the production of Integra products
Ensure technical support to QC, purchasing and production departments
Provide Quality Engineering Support to suppliers including audits/assessments, inspection technique support, verification /validation activities, CAPA and change management. FDA CFR part 820 and ISO 13485 regulations/standards will be the focus.
Addresses Supplier Change Requests in compliance with procedures and regulatory requirements.
Ensures that activities for validation of outsourced processes/products are performed and documented according to procedures and within the defined timeline.
Ensures that Supplier Non-conformances are initiated, dispositioned, approved and investigated according to plans and in compliance with procedures and regulatory requirements.
Escalate supplier quality issues to management as appropriate, develop and propose robust and compliant solutions.
Participates in and leads continuous improvement projects and initiatives.
Participates and supports internal and third-party audits / inspections.
Manages or participates in quality projects as required.
Provides support with complaint investigations as required.
Leads quarterly Supplier Management Meetings for the Columbia site
QUALIFICATIONS
Bachelor’s or master's degree in manufacturing engineering, mechanical engineering, industrial engineering or sciences or a related discipline is required.
Minimum 3 years of experience in quality or manufacturing.
Medical Device or Pharmaceutical experience is required.
Experience or knowledge of ISO 9001 and ISO 13485, 21 CFR 820, requirements preferred.
Travel up to 25% 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:
$71,300.00 - $97,750.00 USD SalaryOur 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 [email protected].
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 - Employer Branding from Integra LifeSciences on Vimeo
Skills Required
- Bachelor's or master's degree in manufacturing, mechanical, industrial engineering or sciences
- Minimum 3 years of experience in quality or manufacturing
- Medical Device or Pharmaceutical industry experience
- Experience or knowledge of ISO 9001, ISO 13485, and 21 CFR 820 requirements
- Experience in FDA and other regulatory controlled environments
- Knowledge of current Good Manufacturing Practices (cGMP) and applicable standards
- Experience conducting supplier audits and supplier assessments
- Experience with CAPA, change management, and complaint investigations
- Experience with verification/validation activities for outsourced processes/products
- Ability to read and understand technical and statistical documents
- Ability to interface with technical and non-technical personnel and work in a matrix environment
- Experience using analytical tools to drive data-based decision making
- Willingness/ability to travel up to 25%, including possible international travel
What We Do
Integra LifeSciences, a world leader in medical technology with headquarters in Princeton, New Jersey, was founded in 1989 with the acquisition of an engineered collagen technology platform used to repair and regenerate tissue. Since then, Integra has expanded its base regenerative technology product portfolio to include surgical instruments, neurosurgical products and advanced wound care products, through global acquisitions and development of new and innovative products and technologies to address unmet patient needs and improve outcomes. Integra is a global leader in neurosurgery and offers a broad portfolio of products and solutions for dural access and repair, cerebral spinal fluid management and neuro-critical care. Our regenerative tissue technologies include products that address soft tissue, nerve and tendon repairs and for the treatment of acute and chronic wounds, burns, as well as for plastic and reconstructive surgery. The company has offices, manufacturing and research facilities in Asia, Australia, Europe, Middle East, and the Americas. Integra products are ubiquitous in many hospital intensive care units and operating rooms around the world. Some of our high quality leading brands include AmnioExcel®, Bactiseal®, CerebroFlo®, CereLink® Certas® Plus, Codman®, CUSA®, Cytal®, DuraGen®, DuraSeal®, Gentrix®, ICP Express®, Integra®, MatriStem® UBM, MAYFIELD®, MediHoney®, MicroFrance®, MicroMatrix®, NeuraGen®, NeuraGen® 3D, PriMatrix®, SurgiMend®, TCC-EZ® and VersaTru® and are available through a combination of directly employed sales representatives, distributors and wholesalers
