Global Supplier Quality Engineer II

Integra LifeSciences; Plainsboro Township (NJ); Hybrid; USD 71,000 - 98,000; Full time

Benefits offered by this job

401(k)

Medical insurance

Dental insurance

Vision insurance

Life insurance

Disability insurance

Company-wide benefits

Job summary

Integra LifeSciences is seeking a Global Supplier Quality Engineer II to support supplier quality at our Plainsboro, NJ site. You will lead supplier audits, maintain supplier quality requirements, and provide QA leadership to contract manufacturers and raw material suppliers.

This hybrid role requires onsite presence at least three days a week, with travel up to 25%. Key duties include audits, CAPA, change control, supplier quality agreements, and ensuring compliance with FDA CFR 820 and ISO

Qualifications

• Bachelor's or master's degree in manufacturing engineering, mechanical engineering, industrial engineering or sciences or a related discipline.
• Experience in quality or manufacturing (minimum 3 years).
• Medical Device or Pharmaceutical experience is required.
• Familiarity with ISO 9001 and ISO 13485, 21 CFR 820 preferred.
• Travel up to 25% with possible international travel.
• Experience in FDA regulatory environments.
• Strong collaboration in a matrix environment.
• Ability to read and understand technical and statistical documents.
• Knowledge of cGMP and applicable standards.
• Experience using analytical tools to drive data-based decisions.

Responsibilities

• Establishes and maintains an up-to-date Approved Supplier List.
• Plans and executes supplier audits in a timely manner.
• Conducts supplier audits per GMP, ISO, and regulatory requirements.
• Ensures measurement systems monitor supplier quality and prevent defects.
• Maintains supplier quality agreements for production suppliers.
• Provides technical support to QC, purchasing and production departments.
• Supports audits, inspections, CAPA, and change management per FDA/ISO standards.
• Addresses supplier change requests per procedures and regulatory requirements.
• Ensures validation of outsourced processes/products per procedures and timelines.
• Manages supplier non-conformances and investigations.
• Escalates supplier quality issues and proposes robust solutions.
• Leads continuous improvement and supplier management meetings at the Colombia site.

Skills

Supplier quality leadership

Auditing / supplier audits

CAPA and change management

Data-driven decision making

Cross-functional collaboration

Reading technical documents

Education

Bachelor's or Master's in Engineering/Related

Tools

Analytical tools

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

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 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

• medical
• dental
• vision
• life insurance
• short- and long-term disability
• business accident insurance
• group legal insurance
• savings plan (401(k))

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].

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.

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