Sr. Quality Assurance Manager

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Our client, a leading medical devices industry, is currently seeking an accomplished Sr. Quality Assurance Manager to join the team. Here is an overview of the role:

1) Review product conformance and ensure compliance
2) Ensure the quality system is compliant with associated regulations and metrics are being utilized
3) Provide expertise, support, and guidance
4) Collaborate with Regulatory Affairs, in interpreting governmental regulations, agency guidelines, and internal policies in regards to the quality management to ensure compliance and effectiveness
5) Link with authorities and serve as a quality management representative between the company and various governmental agencies
6) Contribute to efforts on process improvement, talent management and other management initiatives to maintain regulatory affairs
7) Assemble and verify archival regulatory documentation
8) Ensure all affected parties are kept abreast of quality issues affecting products and projects
9) Provide guidance on compliance, counsel technical, and business groups to establish direction based on available data and quality considerations
10) Support the creation, review, approval and improvements of all labeling and advertising both internally and externally
11) Review acceptability and quality status of new products, ingredients, and processes
12) Review QC documents relating to product stability and shelf life
13) Ensure the completion and review the content of internal audits for regulatory compliance
14) Maintain adequate knowledge and expertise in product quality and environmental compliance requirements
15) Provide quality systems guidance, training and leadership to department and organization
16) Establish, document and implement superior process control & monitoring systems
17) Apply engineering evaluation and experimentation expertise to ensure that continuous improvement in product and process capability
18) Manage quality audits and analyze findings, recommending modifications in products or standards
19) Identify opportunities and lead the implementation for system compliance improvement
20) Identify quality initiatives and lead cross-functional teams to complete them
21) Apply sound, systematic problem-solving methodologies in resolving quality issues
22) Manage risk analysis maintenance
23) Assess resource requirements to maintain quality support, ensuring that employee competencies are appropriate
24) Utilize Six Sigma and other quality tools to implement process improvements to enhance product quality
25) Reduce process variance by identifying improvement opportunities in regulation compliance, device, process, and system quality, and cost reductions
26) Foster continuous quality compliance and improvements
27) Maintain effective quality metrics
28) Define and execute activities to resolve decreases in performance
29) Manage and develop a team of quality technicians
30) Formulate sampling procedures and designs
31) Develop forms and instructions for recording, evaluating, and reporting quality and reliability data
32) Manage product labeling compliance and keep product specifications current
33) Investigate customer complaints
34) Reduce risk through effective system design, implementation and maintenance
35) Supervise and manage subordinate reports and proactively engage with the Human Resources Manager to ensure the company appraise
36) Develop and identify future talent potential in the existing and future quality and regulatory team


  • 1) A university degree is required (preference will be given to those with degrees in a 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 medical devices industry is strongly preferred
    4) Preference will be given to people with recent experience in QA management

    This is an amazing opportunity for someone with a great attitude who isn’t afraid to roll up their sleeves and get things done. Our client believes in adding value to each and every thing they do and is looking for someone with similar values.


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: 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: