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Quality Manager I

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:  Onsite
Onsite Location(s): 

Arden Hills, MN, US, 55112

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 Quality Manager I will lead a team of supervisors, engineers, and technicians to support Manufacturing  New Product Development, and Quality Systems. He/she/they will direct projects to ensure the manufacture of high-quality products and facilitate compliance with regulatory requirements. He/she/they will partner with Production, Manufacturing, Engineering, R&D, and Process Development to drive continuous improvement in quality, cost, and delivery on commercial products. He/she/they will ensure that new products are implemented with key process controls and product checks in place.

 

Your responsibilities include:

  • Develops, establishes and maintains quality assurance programs, policies, processes, procedures and controls ensuring that performance and quality of products conform to establish standards and agency guidelines to ensure lasting customer satisfaction.
  • Implements a staffing plan by identifying resource requirements, writing justifications for additional staff, obtaining approval for changes, and coordinating the selection process with Human Resources
  • Develops direct reports by securing appropriate training, assigning progressively challenging tasks, applying progressive disciplinary action as appropriate and conducting formal written and verbal performance reviews.
  • Monitors daily work operations and provides direction and guidance to experienced exempt employees, or skilled nonexempt staff to achieve unit or project goals.
  • Interacts with internal and external customers regularly by responding to requests and explaining procedures.
  • Contributes to the development and monitoring of area budgets through regular analysis of cost and spending.
  • Identifies, develops, and implements processes to improve department performance.
  • Interfaces with manufacturing, engineering, customer, vendor, and subcontractor representatives to determine responsibilities and solutions.  
  • Monitors department activities and records to ensure compliance through critical decision making.
  • Provides manufacturing support by defining work assignments directed to address manufacturing process defects and implement process improvements.
  • Directs Quality staff to support new product development by defining projects focused on new products/process development based on coordination with management, project leaders, & design engineers.
  • Implements improvements to Quality Systems and tools by directing staff to gather data on existing quality tools, identify weaknesses, and research/select new tools based on findings.

 

Required Qualifications:

  • Minimum of a Bachelor’s degree 
  • Minimum of 4 years of related work experience 
  • Minimum of 2 years direct supervisory experience with a passion for leadership
  • Experience in medical device or other regulated industry 

 

Preferred Qualifications: 

  • Technical degree in engineering strongly preferred
  • Previous experience leading technical teams in manufacturing environment strongly preferred
  • Experience in the NCEP/NCMR and CAPA including department process management and documentation
  • Demonstrated success in the audit process and use of audit controls
  • Project management experience from inception through delivery and maintenance 
  • Experience with risk assessment process and documentation

 

 

Requisition ID: 540709

 

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: Minneapolis

Job Segment: Manufacturing Engineer, Quality Manager, Compliance, Medical Device, QA, Engineering, Quality, Legal, Healthcare

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