Work Schedule
Standard (Mon-Fri)

Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

Job Description

How will you make an impact?

Being a strong leader of a multi-disciplined team with objective input and expertise in Quality systems, business process excellence, structured problem solving, Environmental and Regulatory compliance.

We ensure our brand meets customer needs, follows laws and industry standards, and defines quality, compliance, and safety for Perfect Quality, Perfect Design, Perfect Order, and Perfect Service. We drive improvements through a structured operating rhythm.

• Build and drive a QA strategy and vision for the Material and Structural Analysis Division US sites that supports growth.
• Provide groundbreaking leadership to the quality function to promote strong quality values to ensure customer and business expectations are continuously met and exceeded.
• Lead and encourage the quality function for MSD US sites to optimally deliver business objectives.
• Drive continuous improvement activities and projects to reduce waste.
• Steer and develop the system to fulfill international quality system requirements (ISO 9001/14001) to enable business growth.
• Translate applicable regulations and standards into operational requirements for sites to implement within sufficient lead-times.
• Strengthen and manage Corrective and Preventive Action System. Coordinate with different departments to identify actions needed, ensuring accurate details and timely completion.
• Build cross-functional alliances with local and corporate teams to ensure participation in and understanding of associated initiatives.
• Collaborate with Human Resources to assure training is available to all employees regarding the Quality System and the Quality Policy.
• Lead key quality business metrics that align with customer expectations to assure year-over-year improvement.
• Promote Customer delight by serving as the primary liaison on quality for both internal and external suppliers, customers, and partners.
• Lead and report on process quality trends, closely work with other partners to report on product quality trends.

• B.S. or equivalent experience in Engineering or scientific subject area.

• 10+ years of quality and regulatory experience working in an ISO 9001/14001 environment.
• Proven success in managing teams.
• Hands-on experience in leading CAPA system.
• Experience with FMEA (Failure Mode and Effects Analysis), SPC (Statistical Process Controls), and other risk management tools.
• Successful experience with problem-solving techniques such as PPI (Practical Process Improvement), 8D (8 Disciplines Model), DMAIC (Define Measure Analyze Control), PPS (Practical Problem Solving).
• Experience with Lean or Six Sigma improvement systems.
• Knowledge of high-tech environment, and specifically capital equipment.

• A conclusive leader who's able to encourage and empower teams and can clearly communicate goals and objectives.
• ASQ Quality Manager and / or ASQ lead auditor training completed.
• Be pro-active and hands-on and ready to roll up the sleeves to fill in where required in meeting the site or departmental objectives.
• Ability to travel domestically approximately ≤25% of the time.

• A choice of national medical and dental plans, and a national vision plan
• A wellness program, and valuable health incentive opportunities for company contributions to a Health Reimbursement Account (HRA) or Health Savings Account (HSA)
• Tax-advantaged savings and spending accounts and commuter benefits
• Employee assistance program
• At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, short- and long-term disability, and volunteer time off in accordance with company policy
• Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan
• Employees' Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount