Job Summary

This Supplier Quality Engineer II role serves as a key quality representative supporting contract manufacturers and raw material suppliers involved in the production of Integra products. The position is responsible for supplier audits, supplier performance monitoring, CAPA and nonconformance management, supplier change control, quality agreement management, and validation activities while ensuring compliance with FDA 21 CFR Part 820, ISO 13485, and other applicable regulatory requirements.

The ideal candidate will have experience working in a regulated medical device or life sciences environment and possess a strong understanding of supplier quality systems, root cause investigations, and quality engineering principles. This role partners closely with Quality Control, Manufacturing, Purchasing, and supplier organizations to drive continuous improvement, resolve quality issues, and ensure supplier compliance. It is an excellent opportunity for a quality professional looking to influence supplier performance, support business continuity, and contribute to the delivery of safe and effective medical products.

Job Description
• Provides quality assurance leadership to select contract manufacturing sites and
raw material suppliers engaged in the production of Integra products
• 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
• Establish and ensure Supplier Quality Agreements are up to date for applicable
suppliers engaged in the production of Integra products
• Report on contract manufacturer performance metrics
• 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
• Manages or participates in quality projects as required
• Provides support with complaint investigations as required

Job Requirements

Required
• A minimum of a Bachelor's Degree in an Engineering, Life Science, or a related
technical discipline. Candidates with an equivalent combination of
education and experience will also be considered for the position.
• Minimum 3 years of professional work experience in a GMP and /or ISO regulated
industry.
• Knowledge of Medical device standards and regulations such as ISO13485, 93/42
EEC, 21 CFR part 820.
• Strong communication, teamwork, and organizational skills are essential
• Strong analytical problem solving and root cause analysis skills
• Use of ERP, PLM systems
• Use of Microsoft office tools
• Knowledge of statistical techniques

Preferred
• Experience working in a Medical Device or Life Science manufacturing environment.
• Operations supplier quality experience, with a strong understanding of process
validation (IQ, OQ, PQ).
• Auditor Certification to ISO 13485:2016.
• Experience or knowledge with the machining processes, injection molding, and/or
electro-mechanical components/assembly.

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 trainingIn addition to base pay, employees may be eligible for bonus, commission, equity or other variable compensationYour 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