Job Description

JOB SUMMARY:

This role oversees all aspects of supplier quality, from supplier selection to quality improvement plans. It requires leadership skills, extensive experience in problem-solving, and a thorough understanding of medical device manufacturing and quality systems. Can provide guidance to others.

ESSENTIAL/PRIMARY DUTIES:

• Conducts activities concerned with the quality assurance of a given commodity set by working closely with suppliers, manufacturing, purchasing, and supplier quality.
• Establishes standardized processes and analyzes process metrics.
• Collaborates with leadership and other cross functional departments to align decisions with organizational goals.
• Acts as a technical lead, manages significant systems, uses strategic planning, and mitigates risk.
• Leads risk assessment, validates assessments, and engages with executives to communicate high-level risks.
• Participates in new product development teams and component qualification process as needed to carry out approvals for given components.
• Leads the development of supplier controls QMS through regulatory and compliance knowledge (FDA CFR820 and ISO 13485).
• Has a commodity focus that is largely comprised of custom engineered components and OEM products and leads strategic planning for supplier quality and sourcing at the organizational level.
• Conducts and documents regular visits/audits to assigned suppliers to review manufacturing processes, quality systems/controls, pre-launch readiness, root cause identification, corrective actions, and process improvement opportunities.
• Applies domain mastery to the application and advancement of engineering methods and tools. Champions six sigma techniques and drives standardization through continuous process improvement.

SECONDARY DUTIES:

• Assists in developing and maintaining supplier quality improvement programs and metrics.
• Participates in front or back rooms during MDSAP (or equiv) audits.
• Assists in internal audits as needed.
• Assists as purchasing controls rep for ISO13485/ 21 CFR820 during external audits.

EDUCATION and/or EXPERIENCE:

Bachelor’s degree in engineering or related field and 6+ years of relevant experience, or equivalent experience. Six Sigma Black belt required to hire.

COMPETENCY and/or SKILL:

• Familiarity with ISO 13485 and 21 CFR 820 with a focus on purchasing controls
• Ability to effectively communicate technical strategies and decisions to executives
• Ability to act as an expert problem solver in areas of expertise.

SUPERVISORY RESPONSIBILITIES:

• Provides leadership, coaching, and/or mentoring to engineer II and III’s.