QA Manager

Job Title: Quality Engineering/Quality Manager

Reports to: Plant Manager

Location: Lehigh Valley Area, PA

FLSA Status: Exempt

Scope of Responsibilities

• Achieve quality assurance operational objectives by contributing information and analysis to strategic plans and reviews; preparing and completing internal action plans; implementing production, productivity, quality and customer service standards; identifying and resolving problems; completing audits (internal/external) determining system improvements; implementing change.
• Develops quality assurance plans by conducting hazard analysis, identifying critical control points and preventative measures, establishing critical limits, monitoring procedures, CAPAs and verification procedures, monitoring inventories.
• Validates quality process by establishing product specifications and quality attributes; reviewing production measurements; documenting evidence; determining operational and performance qualifications.
• Responsible for company actions necessary to support product Safety including:
  • Training
  • Enforcement
  • Resource Planning
• Establish statistic process controls for applicable processes.
• Manage customer complaints (CARs) through the complaints library. Oversight of the plant investigation of root cause, short term and long term corrective actions along with complaint follow-up. Validation that the appropriate plant personnel are providing the proper investigation and resolution. Manage and report on CAR database through tracking and trending of complaints. Manage and report on daily non-conformances found during production over all shifts. Record, analyze and reference daily non-conformances as needed for track/trends/customer complaints/maintenance/item issues.
• Project Management: Oversee quality based plant projects (i.e. decreasing customer complaints for top 5 categories).

Additional Responsibilities:

• Conduct Internal Audits: Initiate and track root cause/corrective action performance. Assist plant in designing continuous improvement steps for production and quality.
• Document Control Management: For all corporate and local standard operating procedures (SOPs) and/or work instructions. Create, read, write, update, and annually review all Alpha documents as needed.
• Weekly reporting of the state of plant quality through various tracking/trending/monitoring reports.
• Manager MRB (Material Review Board) and Quarantine. Oversee documentation of rework, rework/quarantine closure and report losses to customer service/management as needed.
• Manage PDS (Pre-Delivery Shipment) sampling for required customers. Weekly update Quality with upcoming PDS lots and review for shipment.
• Review all Quality/Production batch files for GDP, GMP, etc. Organize and index all batch files into electronic database for plant access. Save and archive all paper records as needed.
• Manage plant HACCP program and CCP's list.
• Assist with Validation New Equipment Qualification Protocols (NEQP).
• Have knowledge of FDA requirements (21 CFR) for food/drug safety.
• Updates job knowledge by studying trends in and developments in quality management, participating in educational opportunities, reading professional publications, maintaining personal networks, participating in professional organizations.
• Head the Food Safety program directive. Train all applicable employees on the Food Safety Requirements as described in the GFSI/FSSC 22000 compliance requirements for the company.

Production Supervisor Skills and Qualifications

Minimum Requirements

• Must have direct management experience. Professional development of Quality personnel is required.
• Ability to work with all levels of employees within the organization.
• Outstanding character and personal values that are aligned with the company's culture.

Required Experience & Education

• Bachelor's degree in engineering (QE, EE, ME, etc.) from accredited college or university.
• Minimum five years experience in Quality Engineering/Quality Manager roles.

Preferred Experience & Education

• Quality Certification (CQE, CQA, ASO, etc.) preferred.
• Industry specific experience preferred.
• Experience with Quality Certification implementation and requirements preferred.
• Experience with utilizing statistics and establishing statistic process controls for Manufacturing.