Quality Assurance Manager

Sterling-Hoffman Executive Search Located in: Ontario
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We are seeking a driven individual with a passion for the life sciences industry. One of our clients is looking to add a strong Quality Assurance Manager to their team. Responsibilities include:

1) Supervise Quality Assurance team members
2) Oversee manufacturing batch record review and release, finished goods retention and material rejection duties
3) Ensure speed and efficiency to move to a proactive and preventative production model
4) Develop, implement and monitor department KPIs to ensure work is performed efficiently with a focus on quality and customer service
5) Ensure all record and batch review processes meet expected throughput and customer service requirements
6) Facilitate and promote the use of appropriate problem solving and investigative techniques for effective root cause analysis and successful corrective and preventative actions to expedite closure of investigations as efficiently as possible
7) Manage customer communications/relationships related to non-conformance events
8) Oversee management of consumer complaints response program to ensure that it is maintained in a state of compliance
9) Review and approve consumer complaint responses
10) Provide support to operations, ensuring consistent application of quality techniques
11) Resolve quality issues for capability, tolerance and material issues
12) Participate in and help facilitate cross-functional investigations to accomplish efficient and effective root cause determination and CAPA
13) Apply appropriate statistical techniques and measurement analysis tools
14) Participate in quality and business process improvement plans and initiatives
15) Participate in Advanced Product Quality Planning (APQP) to determine appropriate use of existing and new measurement tools during process design and improvement
16) Participate in Failure Mode and Effect Analysis (FMEA) development and maintenance throughout the lifetime of the process/product
17) Support QMS and ensure that the QA department capitalizes on improving efficiency and reducing non-value added tasks and complexity
18) Perform quality impact assessments for the QC laboratory, operations and facility/utility investigations
19) Ensure audit readiness for all QA activities and responsibilities
20) Monitor quality and performance metrics to ensure repetitive/systemic issues are raised and corrected


  • 1) A university degree is required. Although all candidates are welcome and encouraged to apply, preference will be given to those with degrees in a relevant field
    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 candidates with recent experience in quality assurance management This position is critical to the team and requires a talent who is both driven and highly skilled. We are looking for real go-getters here, so if you are both qualified and ready to make an impact, please apply!


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


Seniority Level:
Management / Supervisory
Preferred Industry Background:
Managing a team of:
Required Travel:

Base Salary:
Other Compensation: