Boston Scientific Quality Manager 

United States, Minnesota 

343647493

About the role:The Quality Manager leads a team of quality engineers and technicians to support the Capital Equipment & Externals Business Unit. Directs projects to ensure the manufacture of high quality product and to facilitate compliance with regulatory requirements.

Your responsibilities will 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, applying progressive disciplinary action as appropriate and conducting formal written and verbal performance reviews.
• Monitors daily work operations and provides direction and guidance to 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).
• Facilitates quality system and product focused audits with external regulators
• Contributes to the development and monitoring of area budgets through regular analysis of cost and spending.
• Translates department goals into individual objectives
• Identifies, develops and implements processes to improve department performance.
• Monitors departments activities and records to ensure compliant 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 and integration products by defining projects based on coordination with management and project leaders
• 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.

Required qualifications:

• Bachelor’s degree
• Minimum of 4 years of related experience
• Minimum of 1 year of direct leadership experience
• Medical device industry experience

Preferred qualifications:

• Audit support experience
• Experience communicating and collaborating with a broad range of stakeholders

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.

Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID-19 vaccination.

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.