Senior Supplier Quality Engineer

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.

About Us

Founded in 1915, Midmark Corporation is the only company transforming healthcare experiences through innovative design within the medical, dental and animal health environments. With more than 2,200 teammates worldwide, Midmark focuses on harmonizing space, technology and workflows, creating a better experience for caregivers and patients at the point of care. The Midmark headquarters and innovation hub are located in Versailles, Ohio, which is also home to the Midmark Experience Center, Design Center, Technology Center and our largest manufacturing facility. Midmark maintains eleven additional locations in the United States, including four innovation hubs, and has subsidiaries in India and Italy.

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