Senior Supplier Quality Engineer

Additional Location(s):  N/A

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance

At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we’ll help you in advancing your skills and career. Here, you’ll be supported in progressing – whatever your ambitions.

About the role: The Senior Supplier Quality Engineer will play a key part in leading performance improvement of suppliers and increasing the supplier’s capabilities to consistently meet Boston Scientific’s requirements. Additionally, the Supplier Quality Engineer will support global sourcing, supplier manufacturing operations, and global quality systems by participating in global communities of practice and value improvement projects. The SFMD Supplier Quality Engineering team is looking for high energy, driven, passionate people, looking to not just change jobs, but start an amazing career!

Your responsibilities will include:

• Assess suppliers for technical, quality and manufacturing capabilities. Assess supplier changes for product and compliance impact.
• Responsible for supplier qualification, onboarding and performance monitoring based on supplier risk, Assess & drive reactive as well as proactive supplier project(s)/investigations partnering with Supplier Engineering, Commercial Sourcing, Design Assurance.
• Generate and review quality plans, agreements, product specifications, component qualifications, design verification/validations, and process validations.
• Plans and leads ISO 13458 focused audits of suppliers to assess compliance with regulatory and Boston Scientific requirements, including determining assessment outcomes and driving corrective actions/proactive preventative actions to closure.
• Evaluates and communicates quality issues to suppliers and applies sound, systematic problem-solving methodologies in identifying, prioritizing, and resolving quality issues. Reviews and approves supplier corrective action plans and verification of effectiveness documentation.
• Develops solutions to a variety of complex problems of diverse scope and complexity where analysis of data requires evaluation of identifiable factors. Exercises authority and judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions. Has a broad knowledge of a variety of alternatives and their impact on the business unit.
• Plans and organizes non-routine tasks with approval. Initiates or maintains work schedule and priorities. Plans and organizes project assignments and maintains project schedules.
• Works under general direction regarding the direction and progress of projects and special assignments. Independently determines and develops approach to solutions.  Interprets, executes and recommends modifications to company policies. Assists in establishing departmental policies and procedures. Work is reviewed upon completion for adequacy in meeting objectives.
• Establishes and cultivates a wide range of business relationships to facilitate completion of assignments. Interacts with suppliers. Participates in determining goals and objectives for projects. May lead projects within the function or department and/or represents a specialized field in larger project teams. Influences middle management on business solutions.
• In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.  Assures that appropriate resources (personnel, tools, etc.) are maintained in order to assure Quality System compliance and adherence to the Quality Policy.  Establishes and promotes a work environment that supports the Quality Policy and Quality System.
• Champions 100% compliance to company policies and SOP’s. Identifies and advises management on potential improvements to quality systems and processes in the company.

Required qualifications: 

• Bachelor's degree in engineering/technical field such as materials science, chemical or mechanical engineering.
• Minimum of 5 years of related experience. 
• Experience with problem solving quality tools and CAPA.
• Experience in working with mechanical or electrical suppliers.
• Domestic and international travel up to 10%. 

Preferred Qualifications:

• 7 years of related experience. 
• Experience with technical documentation.
• Ability to communicate & influence cross functionally, with suppliers, team members and leadership.
• Articulate communicator: adept at messaging and appropriately scaling information to the intended audience.
• Experience in process validation, design controls, risk management, and CAPA.
• Ability to work independently; organized and self-driven.
• Ability to rapidly learn and use new software applications (e.g., PLM, ERP).
• Leadership experience on a materials or service commodity team.
• Lead auditor of quality systems experience (ISO 13485 or similar).
• Experience with auditing supplier quality systems.
• ASQ certification (CQE, CBA, SSGB, SSBB) strongly desired.

Requisition ID: 594363

Among other requirements, Boston Scientific maintains specific prohibited substance testing requirements for safety-sensitive positions. This role deemed safety-sensitive and, as such, candidates will be subject to a drug test as a pre-employment requirement/ The foal of the drug testing is to increase workplace safety in compliance with the applicable law.

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. Now more than ever, we have a responsibility to apply those values to everything we do – as a global business and as a global corporate citizen.

So, choosing a career with Boston Scientific (NYSE: BSX) isn’t just business, it’s personal. And if you’re a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you!

At Boston Scientific, 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 § 2.2-4312 (2000), 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.