Manager, Engineering - Quality

ICU Medical - Salt Lake City, UT

Full-time - Mid Level

Salt Lake City, UT

Merchant Wholesalers, Durable Goods

About the position

The Manager, Quality Engineering is responsible for overseeing the quality engineering function at the Salt Lake City facility, focusing on validations for a fast-paced manufacturing environment that includes molding and assembly of medical devices. This role involves leadership and mentoring of quality engineers, administration of the Master Validation Plan, and collaboration with various internal and external teams to enhance product quality and compliance with quality management systems (QMS).

Responsibilities

• Provide management and development to Quality Engineers responsible for process validations.
• Drive proactive quality improvements to QMS processes.
• Lead continuous improvement activities to prevent problems and resolve issues efficiently.
• Represent the Quality Organization in business team projects and assess quality strategies.
• Conduct internal audits and lead during regulatory and customer audits.
• Review and approve documentation related to quality processes and validations.
• Develop and monitor Key Performance Indicators (KPI) for validation programs.
• Collaborate with various departments to improve product quality and manufacturing efficiencies.
• Recruit, train, and mentor direct reports, implementing changes to support the manufacturing site.
• Assist in developing departmental goals, budgets, and resource utilization plans.
• Conduct GMP Training for plant employees to ensure compliance awareness.
• Collaborate with other functions to prioritize tasks for achieving business goals.

Requirements

• Bachelor's degree in engineering required.
• Minimum of eight years of industry experience required.
• 2-4 years of management experience required.
• Practical knowledge of validations including molding processes and assembly equipment.
• Strong analytical, problem-solving, and decision-making skills.
• Proven track record of cross-functional collaboration and change management.
• Ability to influence others and work effectively in a team environment.
• Good organizational and time management skills with attention to detail.
• Strong verbal and written communication skills for effective interfacing with various departments.
• Knowledge of national and international regulations applicable to medical devices.

Nice-to-haves

• Prior experience in medical device manufacturing environment preferred.
• Certifications from ASQ preferred.
• Proficiency in Minitab or other statistical software.

Benefits

• Health insurance
• 401k plan
• Paid holidays
• Professional development opportunities
• Flexible scheduling