Job Details

Manager, Quality Assurance, Instrumentation

Title
Manager, Quality Assurance, Instrumentation
Accepting BioReady
Yes
Length
Full Time
Employer

STEMCELL Technologies

Salary
Yearly
not disclosed
Location
Vancouver, BC
British Columbia
Date Posted
07/02/2018 - 08:00
Closing Date
07/03/2018 - 08:00
Job Description
Summary: 

STEMCELL Technologies Inc. is a privately-owned biotechnology company based in Vancouver that helps power leading-edge life science research around the world. Scientists performing stem cell, immunology, cancer, regenerative medicine and cellular therapy research are among those who rely on our cell culture media, cell separation products, instruments, ancillary reagents and contract assay services. We create novel, useful, standardized products of unfailing quality and deliver them to more than 70 countries via our many regional offices plus distribution centres in Vancouver, Seattle, Grenoble and Singapore.  Driven by our love of science and our passion for quality, we see ourselves simply as “Scientists Helping Scientists” – standing by our customers to provide outstanding products, technical support and training.  We have over 1000 science-oriented employees globally, including 250 PhDs/MScs, with most others holding a BSc or engineering degree.  STEMCELL is proud to be the largest Biotechnology employer in Canada.

The Manager, Quality Assurance, Instrumentation role at STEMCELL leads the development and implementation of strategies to maintain the compliance of the Instrumentation division as a whole. It gives the opportunity to exercise independent judgment in evaluating complex problems and applying current methodologies and practices to resolve identified issues and fill identified gaps. It requires future vision for growth and alignment with business strategies. STEMCELL is a dynamic workplace that pursues cutting edge technologies and practices which translates to this role managing complex sources of data that require in-depth critical thinking and reviewing the impact to the department and organization.

Education & Qualifications: 
  • Education:  Masters or Bachelor’s Degree in Engineering.

 

  • Experience:  At least 7+ years’ experience in the regulated medical device industry. Minimum of 2 years management experience.  Experience with implementing and managing Quality Management Systems. ASQ certifications desirable.

 

  • Specialized knowledge:  Extensive knowledge of Quality System regulatory requirements. Knowledge of Health Canada and FDA regulations and guidance. Knowledge of European Device Directive and of applicable guidance documents (MEDDEV, NBMED, etc.). Knowledge in product labeling and promotional requirements. Thorough knowledge of product development process, validation and design control. Instrument safety standards and directives (safety testing, RoHS, etc.). Hardware, systems, software design requirements.

 

  • Skills:  Proven ability in coordinating efforts to implement, support, mentor and audit Quality Management System requirements.  Excellent technical report writing and strong ability to understand and analyze technical documents.  Familiarity with Continuous Improvement concepts.  Demonstrates the ability to apply scientific and technical knowledge, critical analyses and decision-making skills to identify and resolve issues in areas including the Quality Management System. Strong leadership capabilities. Excellent negotiation and problem-solving skills. Strong project management and time management skills, and has worked closely with multiple internal and cross functional teams. The ability and the drive to work in a fast-paced environment and have a strong sense of project ownership are essential.

 

  • Other characteristics such as personal characteristics:  Comfortable making presentations before groups; ability to question and not always be satisfied with the status quo; willingness to learn and assume new responsibilities; good interpersonal skills; self motivated and independent work ethic; ability to handle multiple tasks in a fast paced environment.
Duties & Responsibilities: 
  • Ensures appropriate procedures, processes and policies are established and implemented for quality assurance activities to assure compliance with applicable medical device regulations and standards.
  • Defines and implements quality by design and compliant design control for medical devices.
  • Educates trains, advises and coaches business unit employees to ensure adherence to all applicable quality standards for assigned areas.
  • Maintains and improves product quality by completing product, company, system, compliance, and surveillance internal and external audits and leads third party audits as required.
  • Leads QA investigations on product complaints, corrective and preventative actions.
  • Responsible for the development of metrics that report on the effectiveness of processes, status of improvement opportunities and progress against performance objectives to drive Continuous Improvement.
  • Acts as a catalyst for change and improvement in performance/quality.
  • Supports regulatory submissions.
  • Leads multidisciplinary product, program and process improvement and development teams by providing information and compliance support to meet team goals.
  • Exercises independent judgment in developing methods, techniques and evaluation criteria for obtaining results.
  • Provides vision and leadership in overall departmental objectives.
  • Implements strategies in alignment with the overall business goals.
  • Provides technical support to all staff as related to quality practices.
  • Continues exposure to current quality practices through reading, conferences and training courses.
Other Information: 

This is an opportunity to work with highly motivated colleagues in a science-oriented, creative and dynamic environment. We offer a competitive salary, excellent benefits and significant career development opportunities. If you are interested in this challenging and rewarding position, please apply online at https://jobs.stemcell.com/