Sr Quality Engineer Job

Quality       ·       Spencer, IN, US       ·       Full time

Boston Scientific’s hybrid workplace includes remote and onsite roles. By applying to this position, you will have the opportunity to discuss your preferred working location with your Talent Acquisition Specialist.

Remote Eligible:  Hybrid
Onsite Location(s):   Spencer, IN, US, 47460
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.

Senior Quality Engineer

About the role:

The Senior Quality Engineer provides focused quality engineering support in a lead role for site, divisional, or global projects. Develops, establishes and maintains quality engineering methodologies, systems, and practices which meet BSC, customer, and regulatory requirements. Serves as a Quality representative to support departmental, functional, site, divisional and global quality goals and priorities within a collaborative team environment. 

Your responsibilities will include:

• Provides leadership role in championing departmental or cross-functional engineering initiatives.
• Provides project direction, coaching, and mentoring for engineering and technical team personnel as well as direct reports
• Proactively investigates, identifies, and implements best-in-class Quality Engineering practices.
• Establish effective corrective action plans. Lead in implementation of quality assurance plans, process controls, and CAPA systems designed to meet or exceed internal and external requirements.
• Acts as an effective leader or team member in supporting quality disciplines, decisions, and practices.
• Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues, including FMEA.
• Review and approve product, process, software qualification and validation and other change control related documentation.
• Generate internal quality documentation such as quality plans, standard operating procedures and inspection procedures. Ensure BSC regulatory, FDA and ISO compliance in all areas of responsibilities.
• Must comply with requirements of ISO 14001 and BSC Environmental, Health and Safety standards and follow procedures and instructions related to these standards.

What we’re looking for in you:

Basic Qualifications

• 5+ years’ relevant experience and bachelor’s degree in Quality Engineering or related discipline. 
• 3 – 5 years’ medical device experience.
• Demonstrated used of Quality tools/methodologies including SPC, DOE, GR&R, FMEA, CAPA, process validation (IQ, OQ, PQ) and FDA, ISO/MDD standards. 
• Experience leading projects, coaching, and mentoring for engineering and technical team personnel.
• Demonstrated interpersonal skills with ability to work within a team environment.
• Strong written/verbal communication skills. 

Preferred Qualifications

• Six Sigma problem solving methodologies, and/or ASQ certification

Requisition ID: 509306

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 is proud to be an equal opportunity and affirmative action employer.

Boston Scientific maintains a drug-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.

Nearest Major Market: Bloomington Indiana
Job Segment: Quality Engineer, Senior Quality Engineer, Medical Device Engineer, Six Sigma, Compliance, Engineering, Management, Legal

Please click here to apply.