Quality Manager

Midland-Marvel Recruiters, LLC; Latrobe (Westmoreland County); On-site; USD 80,000 - 100,000; Full time

Benefits offered by this job

Relocation assistance

Job summary

A leading recruitment agency is seeking a quality manager in Latrobe, PA. The ideal candidate will have over 10 years of experience in quality management with proven abilities in ISO 13485 and 21 CFR 820 compliance, specifically within the medical industry. Responsibilities include spearheading compliance efforts, conducting audits, and developing quality training programs. A Bachelor's degree is preferred along with strong knowledge of injection molding and manufacturing safety. Relocation assistance is available for qualified candidates.

Qualifications

• 10+ years of proven experience in Quality Engineering &/or Quality Leadership.
• Familiar with 21 CFR 820 and ISO 13485.
• Solid knowledge of Injection Molding.

Responsibilities

• Spearhead compliance with 21 CFR 820 and ISO 13485.
• Conduct internal audits of business unit operations.
• Drive investigations into complaint issues.

Skills

Quality Management

ISO 13485

Injection Molding

Manufacturing Safety

Education

Bachelor of Science

Tools

MS Office

Job description

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).

Key Responsibilities:

• 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.

Qualifications and Competencies:

• 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.