Quality Manager

Job Purpose: 

Demonstrates commitment to the Quality Policy (patient safety and product quality) through their daily execution of sound quality practices and the maintenance of an effective quality system.  Understands  and complies with all the regulations governing the quality systems.  Ensures their team are aware of their commitment to patient safety and product quality, are current with their training requirements and that they understand and comply with all other regulations governing their work.

Key Responsibilities: 

• Develops and manages a high performance quality engineering team with focus on customer needs, compliance, product quality, and risk mitigation.
• Has the responsibility and independent authority to make decisions related to product quality, including the disposition of non-conforming product.
• Participates in Customer Complaints investigation for areas under their control.
• Is viewed as a leader or expert in the areas of QSR and ISO/MDD standards within ones own group, constantly promoting awareness of best industry practices and making appropriate decisions on a daily basis using the Site QA Director as the final arbitrator on critical quality decisions.
• Develops, directs and executes plans for major segments of complex projects from a quality perspective.
• Reviews and approves operational, test and validation data to establish technical specifications and performance standards for newly designed or modified products and processes.
• Takes a leadership role in developing and implementing new techniques and initiatives to enhance the Quality management system on site and across the Corporation where possible.
• Is key to developing staff on new quality initiatives and assists understanding and rollout of quality initiatives across the department/site.
• Is a champion of continuous improvement with particular focus on product quality through six sigma initiatives.
• Is an effective people manager resulting in a motivated high performance team.  Is an influential team member, fully motivated to achieve and demonstrate best practices in line with the department.
• Works with EHS to identify significant environmental impacts of Boston Scientific operations and to establish goals and targets around significant environmental impacts.
• Works with Production Unit Manager and Engineering Manager to deliver business goals & objectives
• Is familiar with the internal auditing process.
• To establish and support a work environment of continuous improvement that supports BSC’s Quality Policy, Quality System and the appropriate regulations for the area.

What we are looking for: 

• Level 8 Honours Degree in a relevant discipline
• A minimum of 8 years’ experience with progressive leadership responsibilities within a Medical device Quality System regulated organization
• Experience in Operations Quality required, experience in product transfers and product development and advantage  
• Good technical capabilities, communication skills, teamwork abilities and initiative
• Proven ability to work well as part of a team & on own with minimum supervision

At Boston Scientific, we recognise that nurturing a diverse and inclusive workplace helps us be more innovative. It is essential in advancing science for life and improving patient health. We stand for inclusion, equality, and opportunity for all. By embracing the richness of our unique backgrounds and perspectives, we create a better, more rewarding place for our employees to work and reflect the patients, customers, and communities we serve. Boston Scientific is proud to be an equal opportunity and affirmative action employer.  Boston Scientific is committed to providing reasonable accommodations for applicants and employees with a disability. Should you require a reasonable accommodation during the recruitment process, please email TalentAcquisitionIre@bsci.com. 

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