Job Description

Title: Quality Manager

Our client, a leading global company specializing in custom packaging solutions for the medical device and pharmaceutical industries, is seeking a Quality Manager for their location in the Allentown, PA area. The company focuses on designing and manufacturing high-quality packaging using advanced plastic manufacturing technology and stringent quality control measures.

Position Overview

Role: As the Quality Manager, you would be responsible for developing, establishing, and maintaining QA programs, policies, and processes and ensuring the quality performance of our products by performing the following duties personally or through subordinate supervisors and/or the management team.

Responsibilities and Functions:

• Direct and coordinate quality projects of major magnitude and scope, providing significant guidance and approval regarding technical strategies and approaches.
• Develops and monitors department budgets to maximize investments, increase efficiencies, and ensure the quality of our product.
• Ensures processes needed for the QMS are established, implemented, and maintained.
• Manages the following functions or tasks directly or through subordinates: Management Review, Supplier Quality / SCAR, Calibration, NCM Control, Document Control, CAPA, External QMS Audits (Customer Notified Bodies), Corporate Internal QMS Audits, In-process Inspection, and other duties and assignments as directed by Management.

Qualifications:

Education:

• High School Diploma, BS in Engineering Preferred

Experience:

• Required: 5 years in a plastics-related manufacturing environment
• cGMP/cGDP Experience
• ASQ CQE Certification a plus
• Quality Engineering (i.e. DOE, Inference Tests, Normality/Capability Analyses, Correlation Studies, Gage RR, etc)
• Validation / PPAP / Regulatory Compliance – Reach/Rohus Etc.
• ISO 13485 knowledge

Other requirements:

• Excellent organizational and oral/written communication skills
• Maintain a positive work atmosphere by behaving and communicating in a manner that fosters a professional environment for clients and associates
• Able to interface effectively at all levels and communicate effectively as part of a team

Benefits:

• 401(k) match program
• Annual bonus
• Dental, health, and vision insurance
• Paid time off

Location: Allentown, PA

If you are interested in this position, please apply here, send your resume to matthew@mrrecruiter.com, or contact Matthew at (850) 846-3503.

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