Quality Assurance Specialist

Our client, Precision BioLogic, has a new opportunity for a Quality Assurance Specialist, located at their facilities in Dartmouth.

This role is compelling, not only for the associated value of the responsibilities, but also because you would be contributing to the positive culture of a team that has won recognition as a "50 Best Workplaces in Canada".  Precision BioLogic is a privately-held medical device company that develops, manufactures and markets a range of specialty diagnostic products used to assess blood coagulation disorders in over 900 clinical laboratories around the world.

Key areas of responsibilities include:

• Review of manufacturing lot files and release approval
• Pre-production quality inspection and approval
• Incoming materials inspection
• Protocol development related to IQs and OQs
• Auditing functions closely associated with manufacturing
• Component specification development and maintenance
• Trending and troubleshooting
• Support other manufacturing and quality activities as required

Preferred candidate background and expertise:

• One to three years of experience in a regulated life sciences manufacturing environment, ideally medical device or other life science field
• Working knowledge of 21 CFR 820 (FDA's Quality Systems Regulation) and ISO 13485
• A post-secondary education in a related field, or equivalent combination of education and experience
• Working knowledge of validation, auditing and inspection methods
• Ability to consistently perform quality procedures with a high degree of accuracy
• Ability to work independently or in a team environment with strong interpersonal skills
• Good judgment in solving technical problems and assessing the validity of results
• Good organizational skills and attention to detail
• Excellent written and oral communication skills and computer literate, especially in MS Office

If you meet the qualifications as outlined and are interested in hearing more about this position, please submit your resume to Arlene MacAskill at arlene.macaskill@talentworks.biz. Please quote competition number QAS0110-CB.