Senior Laboratory Quality Engineer

Additional Location(s): US-MN-Maple Grove; US-MN-Arden Hills

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:
Provide Quality expertise to support Arden Hills and Maple Grove preclinical chemistry labs as well as provide guidance to lab staff, ensuring compliance in Quality System activities. Senior Laboratory Quality Engineer will serve as a Quality representative to improve awareness, visibility, and communication on quality initiatives to support assigned lab quality goals and priorities. Identifies and assures optimal process quality within quality system and regulatory requirements. Understands and applies quality principles to support an effective overall quality system.
 
Your responsibilities will include:

• Support the laboratory function to maintain compliance with external regulations and standards (i.e. ISO/IEC 17025, 21 CFR 58), validated methods, internal Policy/SOPs/WI and other regulations as deemed applicable and influences them toward a state of inspection readiness at all times.
• Participate, collaborate, and communicate with the Quality Management and Laboratory Managment on process improvement projects, quality trends and quality improvement projects.
• Conduct internal and external quality assurance audits of systems, testing laboratories, procedures, and controls employed in the conduct of testing activities conducted under ISO/IEC 17025, 21 CFR 58 and validated methods, with support as needed.
• Plan, schedule, and conduct vendor audits.
• Communicate with global preclinical teams and Strategic Sourcing regarding new preclinical vendor requests, current preclinical vendor needs, and future needs.
• Evaluate the adequacy and compliance of systems, operations, and practices against regulations and company documentation through facility/process-based audits and quality monitoring activities. 
• Assesses the accuracy, validity, and quality of the testing laboratory data.
• Communicate final results of quality reviews and audits to responsible management and technical staff during debriefs or other methods as applicable. 

What we're looking for in you:
Required qualifications: 

• BS/BA in Chemistry or related life sciences discipline
• Strong technical and quality knowledge of ISO/IEC 17025, ISO 13485, and/or 21 CFR 58
• Strong verbal, written communication skills, both technical and conversational
• 3-5 years Technical Experience with 2 or more years working in a quality role

Preferred qualifications: 

• 5+ years working in the medical device industry or other similarly regulated industry (e.g. pharmaceuticals, biologics, pre-clinical)
• Strong technical and quality knowledge of the application of ISO 13485 in a laboratory setting
• Strong quality knowledge of bioanalytical studies run under 21 CFR 58
• Boston Scientific experience
   

 

 

 

Requisition ID: 600938

Minimum Salary: $82600 

Maximum Salary: $156900 

 

The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) – see www.bscbenefitsconnect.com--will vary based on actual location of the position and other pertinent factors considered in determining actual compensation for the role. Compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, among other relevant business or organizational needs. At BSC, it is not typical for an individual to be hired near the bottom or top of the anticipated salary range listed above.

 

Compensation for non-exempt (hourly), non-sales roles may also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).

 

Compensation for exempt, non-sales roles may also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).

 

For MA positions: It is unlawful to require or administer a lie detector test for employment. Violators are subject to crimi