Senior Manager, Supplier Quality; Manufac

Overview

The Senior Manager, Supplier Quality (Contract Manufacturing) leads the external manufacturing Supplier Quality Engineering (SQE) team and oversees daily management, performance, and development of team members. This role partners with suppliers, product development, procurement, and quality teams to ensure compliant materials and strong supplier performance. The position is responsible for managing a broad portfolio of Contract Manufacturing Organizations (CMOs) and distributed product suppliers, implementing quality improvement strategies, and aligning global supplier management requirements.

The Senior Manager develops organizational goals, long-term plans, and global strategies to support business objectives.

• Lead the supplier quality engineering function, providing direction, development, and performance management for the team.
• Participate in short- and long-term planning to establish technical objectives for engineering and supplier quality initiatives.
• Evaluate solutions and modifications to products and projects using technical and managerial expertise.
• Identify improvement opportunities, establish priorities, and drive implementation.
• Manage team budgeting, resource planning, and long-range operational needs.
• Interpret and apply FDA and global regulatory requirements in collaboration with cross-functional teams.
• Ensure compliance with Quality System regulations, corporate policies, and safe working practices.
• Utilize leadership skills to manage multiple unrelated functions and broad engineering and quality challenges.
• Work with business segments, regional teams, and product development leadership to establish long-term goals.
• Guide the application of Design Controls and Quality Management Systems throughout product lifecycle management.
• Oversee supplier performance and quality strategies across CMOs and contract design partners.
• Support global regulatory, quality, and manufacturing requirements.
• Demonstrate expertise in planning, budgeting, associate development, and project management.
• Apply strong understanding of technologies relevant to design, manufacturing, and rapid prototyping.
• Communicate effectively in verbal and written formats.
• Perform other duties as assigned.

• Bachelor’s degree or equivalent combination of education and experience required;
  Bachelor of Science or Master of Science in Engineering preferred.
• Minimum 10 years of experience, including at least 5 years in a supervisory role.
• Experience in program and project management, budgeting, and resource planning.
• Ability to lead engineering teams and apply deep domain knowledge to diverse projects.
• Ability to manage geographically distributed teams and work effectively with CMOs or contract design firms.
• Strong understanding of Design Controls, Quality Management Systems, regulatory requirements, and product development.
• Broad knowledge of management, quality, global regulatory standards, and manufacturing processes.
• Working knowledge of product applications and therapeutic use cases.
• Proficiency with relevant software tools and PC applications.

• Experience in healthcare, medical device, or similarly regulated environments.
• Experience applying CAD, FEA, industrial design, machining, or rapid prototyping methods.
• Strong negotiation, leadership, and strategic planning skills.

• CISSP preferred (if applicable to corporate standards).
• Additional certifications such as CISM, CISA, Microsoft, or Cisco may be considered.
• Passport may be required for travel.

• Domestic and international travel as needed.

• Ability to use personal protective equipment, read, speak, hear, walk, bend, stand, reach, and perform hand/finger tasks.
• Ability to lift up to 50 pounds or move up to 500 pounds using carts or mechanical equipment.
• Reasonable accommodations may be provided.

• Target pay range: $160,400 to $200,600
• Target bonus: 20% of base salary
• Final compensation based on experience, education, skills, internal equity, and market alignment.

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