Quality Manager

Very successful company is looking for a quality manager in Latrobe, PA. Someone who has 5+ years of quality management experience and 10+ years of quality experience. Must be familiar with ISO 13485 working in the medical industry. Plastics experience and 21 CFR 820 knowledge very beneficial.

Will pay relocation for a qualified candidate (US Citizens/Greencard holders only).

• Spearhead compliance with 21 CFR 820 and ISO 13485, ensuring alignment with established processes and surpassing customer expectations.
• Dive into customer expectations through direct interaction via visits, meetings, and conferences, translating these insights into actionable strategies.
• Conduct internal audits of business unit operations, aligning with internal, regulatory, or customer-driven requirements to uphold a culture of continuous improvement.
• Identify and implement quality training programs, empowering our team with the latest industry knowledge and skills.
• Drive investigations into complaint issues, communicate results to customer representatives, and authorize the return of goods when necessary.
• Introduce process controls and statistical analyses to enhance stability and capability, ensuring ongoing operational excellence.
• Chair Material Review Board, Trend Analysis, and CAPA board meetings, and facilitate site-oriented customer and 3rd party audits.
• Monitor and enhance supplier performance, guaranteeing the quality of products supplied to Technimark.
• Implement corrective actions for product nonconformances, deviations, audit findings, and complaints, fostering a culture of continuous improvement.

• 10+ years of proven experience in Quality Engineering &/or Quality Leadership.
• Bachelor of Science is preferred.
• Solid knowledge of Injection Molding
• Proficiency in MS Office and familiarity with Standard Method of Work.
• Strong understanding of Manufacturing Safety.