Senior Quality Assurance/Regulatory Affairs Specialist

StarFish Medical

March 12, 2015

Original postings on the Viatec site are removed after the position is closed, but the posting will be archived here. The original posting was at
http://www.viatec.ca/job-board/13551

Job Category: 
Other
Job Specialization: 
Other
Job
Company Overview: 

StarFish Medical is Canada’s premier medical device development group, an integrated team of 60+ technical product development professionals who work on device design projects for North American and international customers.

At our head office in beautiful Victoria, BC, Canada, you will work in an energizing, purpose-designed 15,000 sq ft facility with some of the best medical device design strategists, designers and engineers to help direct, create and deliver exciting product experiences for varied device markets. Our project areas range from tactical EMS products, surgical tools and consumer diagnostic devices through to high volume disposables, complex IVD systems, imaging technologies and lab equipment.

StarFish offers a collegial, creative and casual working environment. In a recent survey, our employees rated: peers and culture, interesting and meaningful work, and working conditions (flexibility, environment) as the top reasons they most enjoyed working at StarFish.

Why Victoria, BC? Victoria is one of the most stunning cities in Canada. We enjoy a mild climate year-round and the shortest, most beautiful, commute for a city of our size. If quality of life, less time in your car and more time exploring the outdoors is appealing to you, then consider Victoria, where you can: bike on over 400km’s of designated bike lanes/trails (including right by our office), explore 50+ regional and provincial parks, golf year-round, ski and surf, kayak and scuba dive – we enjoy it all!

Job Summary: 

Position Profile

The Senior Quality Assurance/Regulatory Affairs Specialist reports to QA/RA Director.

As a member of the Quality Assurance/Regulatory Affairs team, you will provide quality assurance and regulatory support to medical devices product development and manufacturing departments including ViVitro Labs. Duties may include, but are not limited to the list below.

Job Responsibilities

  • Interact and communicate effectively with all departments of Starfish Medical, ViVitro Labs Inc., the customer base, regulatory bodies and any related contracting services
  • Provide guidance and input on QA and RA issues for PD and Manufacturing projects
  • Manage and drive solutions to Non-Conformance Reports (NCRs), customer complaints and vendor corrective actions
  • Assist Project Managers with documentation required for regulatory submissions
  • Review design inputs for regulatory compliance
  • Review design outputs for regulatory compliance (60601, 14971, RoHS, etc)
  • Deliver customized QMS-in-a-box solutions against customer contracts
  • Support PD and Manufacturing systems improvements as appropriate
  • Review and/or write SOPs and Work Instructions
  • Participate in internal audits of the Quality Management System, prepare audit reports and follow up on non-conformances
  • Work closely with personnel to resolve all issues resulting from review (document corrections, deviations, and clarifications)
  • Review of internal and external change control documents related to the manufacturing process
  • Identify manufacturing process issues based on product testing results
  • Monitor the effectiveness of product Quality testing including: documentation of final test results; review of Device History Records (DHRs) and product release; and provide input on decisions to approve/reject ECRs
  • Follow up on CAPA, NCR and ECR; participate in root cause analysis
  • Provide data for preparation of monthly Quality Assurance reports including quality issues by product,  metrics and summary of any quality problems
  • Participate in Engineering Design Reviews as required
  • Review Quality Plans during product development
  • Participate in developing and training on quality and regulatory courses as needed
  • Participate in Risk Assessment and Analysis sessions as required
  • Communicate with internal groups at Starfish Medical and clients to resolve quality issues to support batch release and disposition
  • Review and approval of verification and validation documents
  • Handles regulatory agency inspections as required
  • Perform other duties as assigned
  • Documentation of final test results
  • Review of Device History Records (DHRs) and product release
  • Provide input on decisions to approve/reject ECRs
  • Periodically assist with preparation of Management reports
  • Provides regulatory support for new products

Qualifications

  • Bachelor degree preferably in technical/science field with a minimum of 5 years of work experience in quality assurance  and/or regulatory affairs role  in GMP (Good Manufacturing Practices) regulated environment, preferably medical devices or equivalent combination of education and experience
  • Management experience in high-tech industry desirable
  • Lead ISO 13485 Auditor, ASQ, SQA or RAPs RAC certification desirable

Job Requirements

  • In depth understanding  of a Quality Management System, and requirements of ISO 13485, Canadian Medical Devices Regulations SOR/98-282, 21 CFR 820 Quality System Regulations, and EU Directive for medical devices 93/42EEC plus amendments and 510 (K) requirements
  • Strong auditing skills with experience of creating and driving improvements based on findings
  • Thorough understanding of quality assurance concepts and practices
  • Detailed oriented
  • Ability to interpret and apply regulations and compliance concepts
  • Excellent communication skills (written and verbal)
  • Demonstrates proactive thinking and actions
  • Ability to read and respond to audiences appropriately
  • Familiar with basic test equipment and basic statistical analysis
  • Computer literate (MS Office)
  • Ability to work with minimal supervision

Additional Requirements

  • Some travel and light lifting may be required.
How To Apply: 

Please e-mail your application to careers@starfishmedical.com. Please ensure the position title is in the subject line. When sending your attachment, please ensure it is in Microsoft Word (.doc), Adobe Acrobat (.pdf) or text (.txt) format. You can also fax your resume to (250) 483-1975.

Compensation will be commensurate with skills and experience. We thank all those who apply to Starfish Medical, but only those candidates selected for an interview will be contacted, no phone calls please.