Quality Assurance Manager

Job Title: Quality Assurance Manager

Location: Lewistown, PA

Duration : Fulltime

Salary Range: (dependent on experience)

• 10% performance-based annual bonus
• 5% quarterly incentive plan
• Relocation assistance available on a case-by-case basis

Job Description

Seeking an experienced Quality Assurance Manager to lead site-level quality systems at its Lewistown, PA manufacturing facility. This role is responsible for developing, implementing, and maintaining all quality programs while driving a strong quality culture across a large, high-volume, FDA-regulated manufacturing operation.

The Quality Assurance Manager will lead a team of quality professionals, partner closely with site leadership, and ensure compliance with regulatory, customer, and internal quality standards. This position supports a 24/7/365 operation with 26 production lines, a 1.8 million sq. ft. facility, and a 10-story ASRS warehouse.

Key Responsibilities

• Lead the development, implementation, and maintenance of site quality systems in compliance with FDA, GMP, ISO, and customer requirements
• Serve as the Management Representative for site quality and compliance systems
• Manage and mentor a team of 6 direct reports within the QA department
• Drive continuous improvement initiatives and promote a strong quality-focused culture across all levels of the organization
• Administer internal and external audit programs and represent the site during regulatory and customer audits
• Oversee CAPA processes and integrate Lean Six Sigma initiatives with quality system activities
• Develop annual quality plans and continuous improvement strategies in collaboration with Operations and Divisional Quality Leadership
• Manage the Master Validation Plan and site validation activities
• Implement, monitor, and optimize electronic quality systems, including Vision QMS and SPC platforms
• Analyze quality data and KPIs, providing regular reports to site and divisional leadership
• Manage departmental budgets, training programs, and professional development initiatives
• Ensure compliance with all safety, GMP, FDA, and ISO requirements
• Act as backup support for the Divisional Quality Leader as needed

Qualifications & Experience

• Bachelor's degree in engineering, Technology, Science, Mathematics, or Business
• Minimum 3 years in a Quality Manager, Technical Manager, or QC leadership role within manufacturing
• Strong preference for experience in FDA-regulated environments (medical device, personal care, or similar)
• Background in process engineering, process management, or medical device manufacturing strongly preferred
• Proven people leadership and team management experience
• Six Sigma Green Belt (preferred)
• ASQ certification or equivalent (CQE, CQA, CQT, or CQM)
• Lead Auditor experience; strong knowledge of CAPA, FDA regulations, ISO 13485, and GMP
• Hands-on experience with Minitab, SPC, and quality systems software
• Strong communication skills and ability to interact with executive leadership, customers, vendors, and regulators
• Consistent work history required (no consulting-only background, no frequent job changes, no employment gaps)

What We Offer

• Competitive salary and incentive compensation
• Medical, dental, and vision coverage starting Day One
• Minimum three weeks of paid time off
• 401(k) with employer match
• Paid parental leave
• Dependent care FSA with employer match (up to $2,500)
• Tuition assistance
• Wellness program with up to $4,000 annual insurance savings
• “Bundle of Joy” benefit (free diapers for new parents)
• And more