Design Assurance Director
3 weeks ago
About the Role:
The Design Assurance Director will serve as the Site Head of Quality (SHOQ) in our Waltham MA and Montreal design sites and will have primary Quality Assurance leadership/oversight for the rapidly growing Pulse Field Ablation (PFA) Franchise, having a direct interaction with Montreal, Heredia and Arden Hills sites.
This is an exciting opportunity to lead a team in developing and sustaining of medical electrical equipment/systems (MEE) and developing a strong System of System Organization focus on building expertise in IEC 60601, Cybersecurity and Reliability and other related topics.
The Design Assurance Director will be responsible for ensuring product quality and compliance through leading the application of Design Control and Risk Management.
Your Key Responsibilities Will Include:
- Recruit, coach and develop organizational talent.
- Foster a diverse workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives.
- Lead a team of employees in the achievement of organizational goals. Coach, direct, develop and motivate a high performing team.
- Keep the organization's vision and values at the forefront of decision making and action.
- Demonstrate effective change leadership.
- Build strategic partnerships to further departmental, organizational objectives and drive a high performing culture.
- Develop and executes organizational and operational policies that affect one or more groups by utilizing technical/professional knowledge and skills.
- Monitor compliance with company policies and procedures (e.g. compliance with FDA, BSI, ISO, etc.).
- Lead quality team on product/system development projects of major magnitude and scope. Key Quality voice of influence on projects.
- Own and drive deliverables related to Design Controls, Risk Management, Product Performance, Quality, and Compliance, key partner in all department goals and objectives. Including leading V&V activities and failure investigations.
- Own and drive commercial product monitoring and all related product sustainment activities.
- Develop and implement quality strategies; seeks innovative approaches to attaining quality goals.
- Directly interface with internal and external audit activities.
Required Qualifications:
- Minimum of a Bachelors degree
- Minimum of 10 years of related experience
- Minimum of 5 years of direct or indirect management experience
- Regulatory compliance experience in the areas of medical devices
Preferred Qualifications:
- Advanced degree in technical fields
- Experience leading technical teams
- Prior R&D, Design Assurance, Product and/or Process Development, Capital Equipment experience
About Boston Scientific:
As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most - united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate.
We recognize that nurturing a diverse and inclusive workplace helps us be more innovative and it is important in our work of advancing science for life and improving patient health. That is why 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 Corporation has been and will continue to be an equal opportunity employer. To ensure full implementation of its equal employment policy, the Company will continue to take steps to assure that recruitment, hiring, assignment, promotion, compensation, and all other personnel decisions are made and administered without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identify, gender expression, veteran's status, age, mental or physical disability, genetic information or any other protected class.
Boston Scientific maintains a prohibited substance free workplace. Pursuant to Va. Code *, Boston Scientific is providing notification that the unlawful manufacture, sale, distribution, dispensation, possession, or use of a controlled substance or marijuana is prohibited in the workplace and that violations will result in disciplinary action up to and including termination.
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.
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