Delivering on the promise of medical innovation begins at Boston Scientific.
By delivering innovative products that help clinicians improve the lives of patients every single day, Boston Scientific makes a profound impact on the quality of medical care around the world. As we continue to transform the field of medical technology, we seek dedicated individuals who possess the integrity and creative spirit needed to thrive in an innovative company. Join a global organization that is fueled by the diversity and talent of its entire workforce.
Principal QE - Risk Management - 31566
Description
General Summary:
Develops, establishes and maintains quality-engineering methodologies, systems, and practices which meet BSC, customer, and regulatory requirements. Serve as a Quality representative to improve awareness, visibility, and communication on quality initiatives to support departmental, functional, site, divisional and corporate quality goals and priorities. Provide quality engineering support within technical development concepts, new product development, operational, or system/services support.
Collaborates with Quality management to recommend, design and implement functional process improvements. May mentor less experienced Quality staff, as well as other cross-functional stakeholders on implementing Quality processes and procedures as appropriate.
Duties and Responsibilities:
· Applies experienced technical quality engineering principles to assigned products or sites and guides them into implementation.
· Champion departmental or cross-functional engineering initiatives.
· Provide project direction, coaching, and mentoring for engineering and technical team personnel.
· Proactively investigates, identifies, and implements best-in-class Quality Engineering practices.
· Identifies and implements effective process and design control systems to support the development, qualification, and on-going manufacturing of products to meet or exceed internal and external quality and regulatory requirements.
· Lead the implementation of assurances, process controls, and CAPA systems designed to meet or exceed internal and external requirements.
· Act as leader or team member in supporting quality disciplines, decisions, and practices.
· Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
· Assure the development and execution of streamlined business systems, which effectively identify and resolve quality issues.
· Advise management on potential improvements or enhancement to quality systems and processes in the company.
· Identify strategies and lead activities that advance the state-of-the-art of the BSC risk management process and its understanding and practice throughout the company. These include compliance, best practices, and integration within the Quality System.
· Establish new and enhance existing relationships with risk management stakeholders at all levels to promote understanding and effective application of the process.
· Provide training, coaching, and technical support to risk management subject matter experts and practitioners.
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Minimum Education & Experience:
- MS in Engineering/Technical field preferred. MBA is also preferred.
- 8-10 years of technical experience, 3-5 years minimum in medical device industry
- ASQ certification is a plus.
Working Conditions:
General office environment, with occasional domestic and international travel to other BSC facilities and or/meetings and conferences.
Competency Expectations:
§ Must be thoroughly familiar with the FDA, ISO, MDD and the Boston Scientific quality requirements associated with developing products in a regulated industry.
§ Broad understanding of US and International regulations including ISO 14971:2009, 21 CFR, 820, 210, 211, and 11 is required, as well as ISO 13485:2003
§ Excellent communication (oral and written) and presentation skills (articulate and persuasive).
§ Pro-active, energetic, self-assured professional with high personal integrity and ability to develop good interpersonal relationships.
§ Mentors and coaches others in technical areas.
§ Proficient with Microsoft Office Suite
