Global Supplier Quality Engineer II

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 Columbia, MD. This individual will provide quality assurance leadership to select contract manufacturing sites and raw material suppliers engaged in the production of Integra products.

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 >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.
  
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  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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