Boston Scientific
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.
Job 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.
Qualifications
Bachelor Degree (HETAC level 8 240 Credits) in a relevant discipline
A minimum of 8 years’ experience with progressive leadership responsibilities
Good technical capabilities, communication skills, teamwork abilities and initiative
Proven ability to work well as part of a team & on own with minimum supervision
Bachelors Degree in Engineering