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Supplier QA Manager I Job

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Date: May 16, 2019

Location: Marlborough, MA, US, 01752

Company: Boston Scientific

 

Primary Location: [[filter2]]
Additional Locations: (n/a)
Requisition ID: 445013

 

 

At Boston Scientific, our products and technologies are used to diagnose or treat a wide range of medical conditions. We continue to innovate in key areas and are extending our innovations into new geographies and high-growth adjacency markets. The Urology and Pelvic Health business unit provides proven, leading solutions to treat kidney stones, benign prostatic hyperplasia (BPH), erectile dysfunction (ED), male incontinence and pelvic floor disorders—more urology subspecialties than any other company. In addition, we continue to invest in gynecologic surgical solutions for the treatment of abnormal uterine bleeding and uterine fibroids. These offerings can help healthcare providers advance patient outcomes, reduce procedure costs and enhance quality—enabling millions of men and women to regain control of their lives. We have a robust product line and pipeline, and we will continue to make an investment in urology and pelvic health.

 

 

About this role

 

  • Leads the team of Quality supervisors/engineers/technicians to support Manufacturing, Supplier Development, New Product Development, and Quality Systems. Directs projects to ensure the manufacture of high quality product and to facilitate compliance with regulatory requirements.

 

Your Responsibilities

 

  • Implements a staffing plan by identifying resource requirements, writing justifications for additional personnel, 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, by meeting regularly, responding to requests and explaining procedures.
  • Interprets and executes policies that affect work processes and personnel within the assigned organizational unit.
  • Contributes to the development of operational policies and procedures that affect personnel within the assigned organizational unit.
  • Monitors compliance with company policies and procedures (e.g. compliance with FDA, BSI, EEO regulations etc).
  • Contributes to the development and monitoring of area budgets through regular analysis of cost and spending.
  • Contributes to the development and monitoring of area budgets through regular analysis of cost and spending.
  • Translates department goals into individual objectives and KRAs.
  • Identifies, develops and implements processes to improve department performance.
  • Monitors departments activities and records to ensure compliance independent action through critical decision making.
  • Provides manufacturing support by defining work assignments directed to address manufacturing process defects and implement process improvements utilizing Quality System tools. May also direct work assignments for quality control auditors.
  • Directs Quality personnel 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 personnel to gather data on existing quality tools, identify weaknesses, and research/select new tools based on findings.
  • Ensures sustaining support of Quality System and regulatory compliance by individually working quality system issues and by delegating project work for maintaining quality system capability.

What we are looking for

  • BS Degree plus 4-6 years of related work experience or an equivalent combination of education and work experience.
  • Proven leadership experience
  • Previous experience with Capital Equipment and Systems
  • Previous experience with Manufacturing Medical Devices
  • Previous experience with New Product Development Projects
  • Previous experience with due diligence initiatives

 

 

Boston Scientific (NYSE: BSX) transforms lives through innovative medical solutions that improve the health of patients around the world. As a global medical technology leader for more than 30 years, we advance science for life by providing a broad range of high performance solutions that address unmet patient needs and reduce the cost of healthcare.

 

Boston Scientific is an Equal Opportunity Employer.

 

Posting Notes: [[filter2]]||(n/a)||Quality||[[mfield2]]


Nearest Major Market: Boston

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