Job Description

Title:  Senior Manager, Supplier Quality(CMO/OEM)

Location:  On-site, Lakewood, CO

Schedule:  M-F 9:00am- 5:00pm-, hybrid 3 days required to be onsite

Pay: $160,000-$200k, 20% bonus (bonus, excellent healthcare benefits, unlimited PTO), relocation assistance

Type:  Direct/Permanent

Start date: Immediate



Overview:
Our client, a global medical device company, is seeking a Senior Manager, Supplier Quality (Contract Manufacturing) to lead the external manufacturing SQE team. This role oversees daily operations and team performance, driving collaboration with suppliers, product development, procurement, and quality to ensure compliant materials. Responsibilities include managing a broad portfolio of CMOs and distributed product suppliers, implementing quality improvement strategies, and aligning with global supplier management requirements to achieve business objectives.



Responsibilities:

• Demonstrates broad management experience across and recognized as an expert within and outside of the Company with fully developed leadership skills and a deep understanding of a broad issues vital to the company working with multiple functions that are unrelated.
• Manages and provides leadership for the functional group’s development, direction, and effectiveness, adhering to organizational policies and processes and supporting overall business and corporate objectives.
• Participates in the short and long-term planning process that establishes technical objectives for a business unit project or functional engineering group.
• Utilizes technical, managerial expertise, and creativity to evaluate proposed solutions, adaptations, and modifications to projects and products used globally.
• Identifies opportunities and initiates prioritization in addition to implementation.
• Completes regular resourcing and budgeting pertaining to a team. Accountable for long-range planning.
• Implements and understands FDA or global regulatory requirements as necessary, in partnership with cross-functional colleagues.
• Ensures compliance with company Quality System regulations and safe working practices.

• Bachelor of Science degree or may have a Master of Science degree in Engineering, preferred.
• Minimum 10 years’ global medical device quality experience, five (5) of which have been in a supervisory capacity.
• A bachelor’s degree or equivalent of education and experience sufficient to successfully perform the essential functions of the job may be considered.
• Requires experience with program and project management methods, budgeting, and resource planning.
• Demonstrated ability to lead an engineering bringing deep domain expertise to diverse projects.
• Ability to manage geographically-diverse teams and collaborators, as well as work effectively and efficiently with CMOs and / or contract design firms.
• Skilled ability to balance commercial and development needs to accomplish global business area goals.
• Advanced understanding and application of Design Controls and Quality Management Systems to product development and lifecycle management
• Work collaboratively with business segment, regional and functional product development leaders to establish and nurture long term goals for the team, department, and function.
• Broad theoretical knowledge of management, quality, global regulatory standards, and or manufacturing.
• Requires working knowledge of the business's products and therapeutic uses.
• Effective leadership, managerial, and strategic planning and global skills.
• Exceptional demonstrated expertise in planning, budgeting, associate development, and project management directed toward achievement of annual, long term, and strategic business plans and goals.
• Requires an exceptional understanding of technology and methods applicable to the area and the ability to determine appropriate application. Examples may include CAD design and packages, FEA packages, industrial design and user-centered design, principles and practices of machining and rapid prototyping.

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Ref: #558-Scientific

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