Global Supplier Quality Engineer II

Integra LifeSciences; New Jersey; On-site; USD 71,000 - 98,000; Full time

Benefits offered by this job

Medical benefits

401(k) plan

Bonus potential

Job summary

Integra LifeSciences is seeking a Global Supplier Quality Engineer II to lead supplier quality programs at the Plainsboro, NJ site. The role conducts supplier audits and maintains supplier quality requirements across contract manufacturers and raw material suppliers, with emphasis on cGMP, ISO 13485, and 21 CFR 820.

The position is hybrid, requiring onsite work at least 3 days per week in Plainsboro, NJ, and involves collaboration across QA, purchasing, and production teams to ensure

Qualifications

• Bachelor's or master's degree in manufacturing engineering, mechanical engineering, industrial engineering or sciences or a related discipline.
• 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 preferred.
• Travel up to 25% with possibility of international travel.
• Experience in FDA and other regulatory controlled environments.
• Strong collaboration in a matrix environment.
• Ability to read and understand technical and statistical documents.

Responsibilities

• Establishes and maintains the Approved Supplier List.
• Plans and executes supplier audits.
• Conducts supplier audits per GMP, ISO, and regulatory requirements.
• Ensures measurement systems monitor supplier quality and prevent defects.
• Maintains Supplier Quality Agreements with applicable suppliers.
• Supports QC, purchasing, and production with technical guidance.
• Provides QA support to suppliers including CAPA and change management.

Skills

Quality engineering

ISO 13485

FDA CFR 820

cGMP

Auditing

Data analysis

Education

Bachelor's or Master's in Manufacturing/Industrial/Mechanical Engineering or related

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 (https://www.integralife.com/careers/total-rewards)

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.