Quality Assurance Manager

Quality Assurance Manager – High-Speed Consumer Products / Medical Device Manufacturing

A leading national manufacturing company with a large facility in the Lock Haven, PA area is currently seeking a Quality Assurance Manager for a Direct Hire opportunity with their growing team. This is an exciting opportunity for an experienced Quality Assurance Manager looking for a company that offers strong leadership opportunities, excellent growth potential, competitive compensation, performance-based incentives, and the opportunity to lead quality initiatives within a large, high-volume manufacturing operation.

The Quality Assurance Manager will lead a team of six direct reports and play a key role in supporting the quality systems and continuous improvement.

Local candidates are preferred, but relocation assistance may be available on a case-by-case basis for well-qualified candidates.

Quality Assurance Manager compensation is anticipated to be $125,000–$135,000 annually, based on each candidate’s experience and education. All well-qualified candidates will be considered regardless of pay rate. The compensation package also includes a performance-based bonus of up to 10% and a quarterly incentive plan of up to 5%.

Qualified Quality Assurance Managers will have most, if not all, of the following skills and experience:

• 7+ years of recent and relevant Quality Assurance, Quality Engineering, Process Engineering, Process Management, or related manufacturing quality experience within a high-volume manufacturing environment.

• 3+ years of current team leadership or management experience, with demonstrated success leading, developing, and managing quality professionals and technical teams.

• Strong process engineering or process management experience is highly preferred. Candidates with significant quality leadership experience within medical device manufacturing environments will also be strongly considered.

• Hands-on experience with CAPA systems, root cause analysis, corrective and preventive actions, quality investigations, process improvement, and continuous improvement initiatives.

• Strong knowledge of FDA-regulated manufacturing environments and ISO 13485 quality management systems.

• Lead Auditor experience and a strong understanding of internal and external quality auditing processes.

• Experience with Minitab and statistical analysis techniques used to evaluate manufacturing processes, identify trends, reduce variation, and improve product quality.

• Six Sigma, Lean Manufacturing, and continuous improvement experience. ASQ certification and/or Six Sigma certification are highly desirable.

• Strong technical knowledge combined with demonstrated leadership experience in a large, complex, high-volume manufacturing environment.

• Ability to lead and support quality initiatives for a 24/7/365 manufacturing operation.

• A BS degree in Engineering, Quality, Manufacturing, or a related technical discipline is a benefit, but equivalent manufacturing quality, process engineering, medical device, and leadership experience will be strongly considered.

• Must be able to work in the United States. No H-1B sponsorship or student visas will be considered.

• Must be able to complete standard pre-hire checks, including background check, drug screen, references, and other employment requirements.