Quality Manager II

Boston Scientific   •  

Fitchburg, WI

Industry: Pharmaceuticals & Biotech


8 - 10 years

Posted 128 days ago

This job is no longer available.

Purpose and Passion • Comprehensive Benefits • Life-Work Integration • Community • Career Growth

At Boston Scientific, you will find a collaborative culture driven by a passion for innovation that keeps us connected on the most essential level. With determination, imagination and a deep caring for human life, we’re solving some of the most important healthcare industry challenges.

Together, we’re one global team committed to making a difference in people’s lives around the world. This is a place where you can find a career with meaningful purpose—improving lives through your life’s work.

About the role:

  • Develops, establishes and maintains quality assurance programs, policies, processes, procedures and controls ensuring that performance and quality of products conform to established company, international (ISO), and governmental regulatory standards and agency guidelines, and to ensure lasting customer satisfaction.
  • Provides expertise and guidance in interpreting governmental regulations, agency guidelines and internal policies to assure compliance.
  • May serve as liaison between the company and external auditors. 
  • Identifies, develops and manages continuous improvement activities. 
  • Work is performed without appreciable direction. Determines organizational objectives, and interprets company policies.
  • Completed work is reviewed, from a relatively long-term perspective, for desired results.
  • Erroneous decisions or recommendations would result in failure to achieve major goals and objectives of the organization.
  • Conducts briefings and technical meetings for top management and customer representatives.
  • Interacts with equivalent level managers concerning matters of significance to the company.

Your responsibilities will include: 

  • Champions continuous improvement and consistent metrics to achieve business result and quality output.
  • Assures implementation of industry best practice quality program and policies.
  • Use technical/compliance information to guide and influence corporate compliance strategies.
  • Drives quality projects of major magnitude and scope.
  • Provides significant guidance and approval regarding technical strategies and approaches.
  • Provides guidance and training to staff, assists subordinates in attaining career goals, motivates individuals to achieve results, and recruits and maintains a high quality staff.
  • Coordinates sessions with the project managers/core team leaders to look for opportunities for staff to learn about new initiatives or volunteer on new projects.
  • Develop and deliver quality system training.
  • Maintains and enhances cross-functional team relationships.
  • Works cross-functionally in identifying and resolving quality issues.
  • Formulates and maintains Quality Assurance objectives and coordinates the objectives with other departments to ensure continuous control over the quality of the finished product.  Initiates internal and external material holds as needed to control product distribution.
  • Establish and support a work environment of continuous improvement that supports BSC’s Quality Policy, Quality System, and the appropriate regulations for the area they support. Ensure employees are trained to do their work and their training is documented.
  • Must comply with requirements of ISO 14001:2004 and BSC Environmental, Health and Safety standards and follow procedures and instructions related to these standards.

What we're looking for:

Basic Qualifications:

  • 7+ years’ relevant experience and Bachelor’s degree in Quality Engineering or related discipline. 
  • 3 - 5 years’ medical device experience is required.
  • Demonstrated used of Quality tools/methodologies including  SPC, DOE, GR&R, FMEA, CAPA, complaint investigation, process validation (IQ, OQ,PQ) and FDA, ISO/MDD standards. 
  • Demonstrated interpersonal skills with ability to work within a team environment.
  • Strong written/verbal communication skills. 
  • Management experience.

Preferred Qualifications:

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

About us:

As a global medical technology leader for more than 35 years, our mission at Boston Scientific (NYSE: BSX) is to transform lives through innovative medical solutions that improve the health of patients.

If you’re looking to truly make a difference to people both around the world and around the corner, there’s no better place to make it happen.

Boston Scientific is an Equal Opportunity Employer – Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Disability, Veteran

Requisition ID: 427677