Director of Quality Assurance

Sterling-Hoffman Executive Search Located in: Montreal,  Quebec
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JOB DESCRIPTION

Our client is seeking a passionate and dedicated individual with a minimum of 2 years of experience in a similar Director of QA role.

1) Oversee the QA and manufacturing functions and provide overall direction for quality management systems to the company
2) Ensure that systems are in place for the testing and documentation of products manufactured by the company
3) Provide final decision on product quality and disposition
4) Ensure that procedures are followed and audited
5) Ensure deviations are fully investigated and that product meets all quality requirements before release and distribution
6) Ensure that quality operations group adequately monitors all systems that impact the quality of product and processes
7) Provide oversight and strategic direction to the company for the implementation and maintenance of ISO13485
8) Ensure OOS investigations, audit findings and regulatory inspection findings are resolved and completed in a timely manner
9) Provide strategic direction for the quality function as the company grows and expands product lines
10) Review all incoming products certificates of manufacture and certificate of analysis, sign off and release or reject each lot based on testing results
11) Release and reject returned items
12) Manage customer enquiries and complaints
13) Comply with all vendors, carriers, to the standards and requirements determined by the company
14) Review and update SOP's for quality management systems regularly
15) Maintain and update specifications in accordance to product changes
16) Review and approve any product changes, document changes, component/ingredient supplier changes, batch size or change in manufacturing procedures by suppliers and manufacturers
17) Liaise with and provide regular reporting to management and to regulatory
18) Ensure approved supplier listing is updated and maintained
19) Liaise with R&D functions to ensure risk management and design control are integrated into early product development as well as commercial product development

CRITICAL REQUIREMENTS

  • 1) University degree is required (preference will be given to those with degree in relevant field, though all candidates are welcome and encouraged to apply)
    2) Appropriate full-time work experience is mandatory (no students or fresh graduates please)
    3) Recent experience in the life sciences industry is strongly preferred
    4) Preference will be given to people having recent experience in quality assurance

    This role is a great opportunity for the right person looking to advance their career with a great company.

COMPANY INFORMATION

Sterling-Hoffman is a retained executive search firm that specializes in representing life sciences and technology companies in matters of high impact talent acquisition. Our clients include market leaders and venture capital-backed startups in industries such as: medical device, biotechnology, pharmaceuticals, enterprise software, clinical research, and laboratory services. You may view more of our jobs here: http://www.sterlinglifesciences.com Your privacy is important to us: we will never share your resume without your permission. Please note that only qualified applicants will receive a response. We encourage you to apply for as many jobs as you believe you are a fit for, but strongly suggest that you include your salary information as job seekers who provide salary information are likely to be reviewed sooner. ===================== TAGS: Biotechnology Jobs, Pharmaceutical Jobs, Medical Device Jobs, Biotechnology Recruiter, Pharmaceutical Recruiter, Medical Device Recruiter, Biotechnology Career, Clinical Research Job, Regulatory Affairs Job, R&D / Scientist Job, Product Manager Job, Medical Device Sales Job, Biotechnology Sales Job, Quality Assurance Job, Engineering Job, Laboratory Jobs, Microbiology Jobs, CEO Jobs, Marketing Jobs, Manufacturing Jobs, Oncology Jobs, Cardiology Jobs, Hematology Jobs, Medical Jobs

JOB INFORMATION

Seniority Level:
Director / VP
Function:
  Quality
Preferred Industry Background:
 
Managing a team of:
N/A
Required Travel:

Base Salary:
Confidential
Bonus:
Benefits:
Other Compensation: