Quality Engineering Project Manager

Quality Engineering Project Manager

We are seeking an experienced Quality Engineering Project Manager to lead quality engineering initiatives supporting manufacturing operations in a large enterprise environment. This role will oversee validation, qualification, product transfer, compliance, and manufacturing quality activities while partnering with engineering, manufacturing, regulatory, and quality teams. The ideal candidate will have strong leadership experience within the medical device or pharmaceutical industry and a proven record of managing global product transfers and manufacturing projects.

This position requires excellent communication skills and the ability to lead cross functional teams in a regulated manufacturing environment.

Key Responsibilities:

• Lead and develop a team of quality engineers supporting manufacturing operations.
• Provide technical leadership for quality engineering activities involving manufacturing processes, equipment, utilities, facilities, and supporting systems.
• Manage validation and qualification strategies, documentation, execution, and lifecycle activities.
• Support global product transfer projects and manufacturing expansion initiatives.
• Partner with manufacturing, engineering, validation, regulatory, development, and quality teams to ensure compliant implementation of new and existing processes.
• Review quality issues, change controls, compliance gaps, and risk assessments while driving appropriate corrective actions.
• Support qualification and validation of equipment, processes, cleaning, utilities, computerized systems, and analytical methods.
• Communicate project status, quality risks, and recommendations to leadership while managing project resources.

Required Qualifications:

• Bachelor's degree in Engineering, Life Sciences, Pharmacy, Physical Sciences, or a related discipline.
• Minimum of 8 years of experience in Manufacturing, Quality Assurance, Quality Control, Research and Development, or Quality Engineering within pharmaceutical, biologics, medical device, or chemical manufacturing.
• Minimum of 4 years of leadership or supervisory experience.
• Hands on experience managing global product transfers within the medical device industry.
• Experience supporting manufacturing and engineering teams with new production line implementation.
• Strong knowledge of validation, qualification, quality systems, regulatory compliance, and cGMP requirements.
• Excellent communication, presentation, and stakeholder management skills.

Preferred Qualifications:

• Master's degree or higher in Engineering or Life Sciences.
• Certified Purchasing Manager CPM certification.
• Certified Quality Engineer certification or formal quality engineering training.
• Experience leading strategic quality engineering initiatives across global organizations.
• Strong negotiation and cross functional collaboration experience.

Benefits:

The Company offers the following benefits for this position, subject to applicable eligibility requirements: medical insurance, dental insurance, vision insurance, 401(k) retirement plan, life insurance, long-term disability insurance, short-term disability insurance, paid parking/public transportation, (paid time, paid sick and safe time, hours of paid vacation time, weeks of paid parental leave, paid holidays annually - AS Applicable)