Boston Scientific Supplier QA Manager - SFMD 

United States, Minnesota 

764930009

Spencer Gregory Hale

Leads the team of Sourced Finished Medical Devices Supplier Quality Engineers to support Manufacturing, Supplier Development, New Product Development, and Quality Systems. Directs projects to ensure the manufacture of high-quality product and to facilitate compliance with regulatory requirements.

Your responsibilities include:

• Implements a staffing plan by identifying resource requirements, writing justifications for additional personnel, obtaining approval for changes, and coordinating the selection process with Human Resources
• Develops direct reports by securing appropriate training, assigning progressively challenging tasks.
• Monitors daily work operations and provides direction and guidance to, experienced exempt employees, or skilled nonexempt staff to achieve unit or project goals.
• Interacts with internal and external customers, by meeting regularly, responding to requests and explaining procedures.
• Interprets and executes policies that affect work processes and personnel within the assigned organizational unit.
• Contributes to the development of operational policies and procedures that affect personnel within the assigned organizational unit.
• Monitors compliance with company policies and procedures (e.g. compliance with FDA, BSI, EEO regulations etc.).
• Contributes to the development and monitoring of area budgets through regular analysis of cost and spending.
• Translates department goals into individual objectives and KRAs.
• Identifies, develops and implements processes to improve department performance.
• Monitors departments activities and records to ensure compliance independent action through critical decision making.
• Provides manufacturing support by defining work assignments directed to address manufacturing process defects and implement process improvements utilizing Quality System tools. May also direct work assignments for quality control auditors.
• Directs Quality personnel to support new product development by defining projects focused on new products/process development based on coordination with management, project leaders, & design engineers.
• Implements improvements to Quality Systems and tools by directing personnel to gather data on existing quality tools, identify weaknesses, and research/select new tools based on findings.
• Ensures sustaining support of Quality System and regulatory compliance by individually working quality system issues and by delegating project work for maintaining quality system capability.

Minimal requirements:

• Bachelor’s degree required in Engineering, Science or other technical degree
• Strong facilitation & communication skills with the ability to successfully interact at all levels of the organization with proven ability to lead individuals, complex projects, and solve difficult technical problems.
• Highly adaptable, willing to accept new ideas, and ability to create, influence, and implement global strategies and policies successfully
• 10% travel
• Personal drive, individual accountability & a strong bias for action

Preferred qualifications:

• MBA, advanced degree
• Global Sourcing or Operations experience
• Experience working with contract manufacturers or OEM suppliers
• Experience in Electrophysiology
• New Product development experience and partnering with R&D and Project Management groups
• Previous experience with technology acquisition & integration
• Experience leading virtual teams
• Experience recruiting & developing a high performance technical team
• Ability to interface with customers to gather insight

Maximum Salary: $ 188300

Compensation fornon-exempt (hourly), non-sales rolesmay also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).

Compensation forexempt, non-sales rolesmay also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).

For MA positions: It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.

Among other requirements, Boston Scientific maintains specific prohibited substance test requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, candidates will be subject to a prohibited substance test as a requirement. The goal of the prohibited substance testing is to increase workplace safety in compliance with the applicable law.