Based in Dartmouth, 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 clinical laboratories around the world. The company has developed a strong reputation in its niche and counts most of the major hospitals and reference laboratories in North America among its direct customers.
We are currently seeking a Senior Manager of Quality to join our Compliance and Product Development team. This role is critical in implementing strategies to manage risk, regulatory compliance and driving business improvements.
Reporting to the Vice President of Compliance and Product Development, the Senior Manager of Quality will execute on the implementation of a complete Quality Management System (QMS) based on best practices as well as support and foster a continuous improvement process across the company – a culture of quality.
- Participate in and support the planning, implementation and oversight for quality activities within a IVD medical device manufacturing operation
- Author, assess and approve all levels of QMS documentation as required
- Liaise with department heads and associated managers to support program requirements and participate in the resolution of QMS/technical issues
- • Work with teams to facilitate quality improvements
- • Support teams in the development of protocols and guidelines
- • Be responsible for customer interface requirements on quality issues
- • Facilitate, through training, the implementation of guidelines and integration into standard practice
- • Carry out contract reviews identifying Quality & QMS related responsibilities
- • Act as the subject matter expert on the fundamentals of Quality
- • Monitor programs to assure that problems are identified and corrected
- • Assess departmental training requirements and personnel performance
- • Provide leadership to the Quality Assurance team
Professional Knowledge & Skills:
- FDA 21CFR820
- Detailed knowledge of ISO 13485 and ISO 14971
- Health Canada medical devices regulations
- CE Marking for IVDs/EU IVD regulations
- Application of quality management disciplines, processes and practices
- Trained in the field of quality assurance/quality management & auditing
- Skilled writer with ability to create comprehensive procedures, reports and correspondence for internal and external distribution
- Ability to coordinate numerous activities concurrently with minimal supervision
- Skilled in the supervision and management of staff
- Knowledge of technologically advanced and complex products
- BS (MS preferred) in biology/life sciences or related field
- Minimum 5 years in a quality assurance role
- Minimum of 5 years in a management capacity with emphasis on quality management
- ASQ Certification
- Experience in regulatory affairs is an asset
- Experience in medical device design control is an asset
Compensation will be commensurate with experience. If you’re interested in joining our team, please submit your résumé in confidence, along with compensation expectations.