Supplier Compliance Specialist

Job Description

Title: Supplier Compliance Specialist

Department: Quality

Reports to: Quality Management

Starting Salary: $84,136+

FLSA Status: Exempt, Full Time

Benefits: Full time associates are eligible for benefits the first of the month following 30 days of service.

• • Medical Insurance
    • HDHP, HSA Plan - Employer Contribution of $1,040/yr.
    • High/Low PPO
    • FSA
  • Dental Insurance
  • Vision Insurance
  • Employer Paid Basic Life Insurance
  • Supplemental Life Insurance
  • Employer Paid Short Term Disability
  • Long Term Disability
  • 401(k) 4% Employer Match
  • Paid Time Off (accrued hours, 120/ year)*
  • 9 Paid Holidays
  • Continuing Education and Seminar Programs
  • EAP Program
  • Fitness Room

Summary: Supplier Compliance Specialist is responsible for managing suppliers, supplier performance, ensuring compliance to applicable standards (including but not limited to REACH, RoHs, Prop 65, etc.), creating and maintaining database of material information, fulfilling customer requests for compliance information, and acting as a resource on supply compliance matters.

Duties/Responsibilities include but are not limited to:

• Drive supplier selection, qualification, and ongoing monitoring activities.
• Support and manage Supplier Corrective and Preventive Action plans and projects to improve quality performance of a supplier.
• Identify and monitor material nonconformances and issue and promptly communicate and resolve supplier-related problems
• Develop and prioritize an auditing schedule as needed to ensure that suppliers are audited for quality system controls and quality standards.
• Collect, catalog, organize and respond on suppliers' documentation regarding Material Compliance.
• Developing and providing appropriate training to associates on regulatory and compliance topics, such as REACH. RoHs, Prop 65.
• Subject matter expert on material compliance regulations and best practices in the medical device industry, providing thought leadership and guidance to the organization.
• Lead initiatives to source and engage reliable suppliers and vendors for additional supply sources and support supplier qualification activities.
• Support supplier selection and qualification activities for NPI and Pre-market supplier quality to ensure that issues and complaints related to material problems are reviewed and addressed with the supplier.
• Other duties as assigned.

Qualifications:

• Experience managing suppliers/supplier quality
• Experience with material compliance requirements (such as REACH, RoHS, etc.) as well as Medical Device regulations both US and international including applicable ISO standards, EU MDR requirements.
• Minimum of 5 years experience working in a regulated industry, such as medical devices or aerospace.
• Bachelor's degree preferred, or equivalent work experience with a proven track record of success.
• Proficient with Microsoft office software, especially Excel and Word. Computer skilled and able to learn Quality Software Systems.

Skills and Abilities:

• Well-developed written and verbal communication skills in English.
• Ability to effectively present information (written and verbally) to senior managers and team members.
• Strong reasoning and investigative skills with the ability to solve problems.

Physical Requirements:

• Must be able to work in manufacturing environments exposed to moving mechanical parts and restricted gowning requirements.
• The employee must occasionally lift and/or move up to 25 pounds.

Notes: This Job Description is intended to be an accurate reflection of the current job as of the document effective date. This job description is not intended to be an exhaustive list of all required skills, duties, responsibilities, or qualifications associated with the positions described herein. The company reserves the right to revise or amend the qualifications, functions and duties of the jobs or to require that additional or different tasks be performed if business circumstances change. Employees are held accountable for performing the duties of their position, as evaluated by documented scorecards and performance management reviews based upon company specified metrics and goals documented in the scorecard for which the employee is made aware and maintains.

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