Director of Quality Assurance

Sterling-Hoffman Executive Search Located in: Montana
(Private and Secure - Guaranteed!)

Sterling-Hoffman Executive Search Biotechnology Jobs Pharmaceutical Careers


Our client is currently seeking a driven and ambitious Director of Quality Assurance to join their team. This is a unique opportunity for a highly motivated professional who has a go-getter attitude.

1) Adhere to company's Standard Operating Procedures (SOPs) and Safety Protocols, FDA Regulations for Human Cells, Tissues and Cellular and Tissue-Based Products (HCT/Ps) and devices
2) Develop and maintain an understanding of company's products and general biological and chemical systems utilized within the department
3) Prepare external audits and client & government regulatory inspections and serve as the primary representative
4) Oversee vendor audits and participate in internal audits in those areas of the quality system that the director is not directly responsible for
5) Respond to audit and inspection findings and prepare summaries for management and associated department review
6) Evaluate the training needs of QA/QC employees and oversee QA/QC training and competency evaluations
7) Maintain documented competency on analytical instrumentation and methods used for testing and inspecting medical devices
8) Designate qualified employees as trainers and serve as the default trainer for the QA/QC Department
9) Analyze Quality Inspection reports, monitor and review process controls
10) Gather and analyze statistical data, perform trend analyses, participate in root cause investigations, and identify targets for corrective action, preventive action and training
11) Oversee QA/QC portion of and participate in, CAPA, Complaint, Non-conformance, and Engineering and Document change control processes and investigations
12) Oversee the development and maintenance of Document Control and Record Control systems that meet FDA, AATB and ISO standards and regulations company-wide
13) Oversee the completion and retention of documentation pertaining to SOPs
14) Write and revise a variety of technical documents including SOPs, quality standards and specifications, training documents and inspection and testing protocols as needed and assigned
15) Participate in the completion of Device History Records or Donor Processing Records as applicable


  • 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 biotechnology industry is strongly preferred
    4) Preference will be given to people have recent experience in quality assurance

    If you imagine yourself working for an excellent company whose employees believe in team work and making great contributions to the industry, this could be a golden opportunity for you.


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:
Director / VP
Preferred Industry Background:
Managing a team of:
Required Travel:

Base Salary:
Other Compensation:
A superb base salary and bonus structure are available; compensation is commensurate with experience and will be discussed with qualified candidates only.