Manager I, Quality

Recruiter: Spencer Gregory Hale

Quality Manager I – Integration

Serve as a Quality representative leading awareness, visibility, and communication of quality initiatives to support global quality goals, priorities, and compliance in the new business development space. Act as a Subject Matter Expert for the Design controls and Quality Systems Production and Process Controls spaces within acquisitions. Develop quality strategies and provide input to maintain compliance and integrate acquired entities and products into the Boston Scientific Quality System.

Your responsibilities will include:

• Acts as an adviser to subordinates and may become actively involved, as required, to meet schedules and resolve problems.
• Cross Functional Communication: Maintains and enhances cross-functional team relationships within divisions, manufacturing plants, distribution centers, and global BSC network. Provide project direction, coaching, and mentoring for engineering and technical team personnel.
• Presents data to upper management related to metrics and key project milestones.
• Provides Integration Guidance: Facilitates development of quality integration strategies and approaches to acquisitions relating to Production and Process Controls and other areas of the Quality System as required. Acts as the Acquisition SME for all aspects of the quality system.
• Technical Expertise: Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues. Experience with design controls and quality systems requirements within a regulated industry.
• Coordinates the quality integration resource loading for the Integration activities.
• Participates in internal and external audits.
• Assures adherence to applicable medical device and electrical safety standards.
• Manages and leads the quality team by providing coaching, ongoing feedback, mentoring, training, and ensuring employees receive development opportunities.
• Responsible for ensuring Quality and compliance in all aspects of projects; Responsible for leading audits from front room and/or back-room roles; identifies and develops tools that facilitate BEST4 processes. Acts as leader or team member in supporting quality disciplines, decisions, and practices.

What we are looking for in you:
Minimum Qualifications:

• Bachelor's degree in Science, Health, or Engineering and 6 or more years of related work experience in the medical device regulated industry.
• Experience within BSC quality systems.
• Potential global and US travel up to 25%.
• Computer skills required including Excel, Word, and PowerPoint.
• Strong presentation & communication skills.
• Working knowledge of US and International regulations and standards applicable to BSC including 21 CFR 806 & 820, ISO 13485:2016, MDD, AIMD, AIMD, CMDR, RDC, JPAL, and MDSAP.

Preferred Qualifications:

• 3 years of experience working on acquisitions.

• Supervisory and performance management/coaching experience
• Experience working with across functions such as Operations, Regulatory, Research and Development, Clinical, and Quality.

Requisition ID: 562206