Quality Assurance Manager

Sterling-Hoffman Executive Search Located in: New Hampshire
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JOB DESCRIPTION

A leading company in the biotechnology industry is currently seeking a Quality Assurance Manager to join their team. For the right candidate, this is a fantastic opportunity with great growth prospects. Details:

1) Review overall quality organization, processes, and structure to identify key areas for growth or improvement
2) Champion critical initiatives to establish long-term quality assurance and regulatory compliance across all departments and functions
3) Conduct a 2015 gap analysis toward implementation of ISO 13485 certification within calendar year 2016
4) Engineer effective facility relocation in Q4 2015 without operational/customer disruption
5) Develop, grow and mentor a team of 8-10 quality professionals across the QA and QC functions
6) Perform root-cause analysis toward assessing immunoassay performance and/or NCMR investigations
7) Co-ordinate and review employee training and understanding of all current QS and regulatory requirements
8) Apply the required industry knowledge, experience and confidence to employ sound risk-based decision making in a regulated environment
9) Collaborate cross-functionally to drive continual product and process improvement
10) Lead QS management meetings (including MRB and annual MRQ) to review and report on the health and effectiveness of company’s Global Quality System
11) Lead both internal/external quality audits as required
12) Review and improve upon current change control processes
13) Review and approve CAPA investigations and close out complaint handling cases managed by technical support
14) Evaluate and document all medical device reporting requirements under 21 CFR 820
15) Review and approve product quality prior to release into general inventory
16) Develop “Fit-For-Purpose” QC testing specifications (in-process/final release) for all products to ensure both regulatory compliance and reliable product availability
17) Review and approve documents and procedures for both application and accuracy

CRITICAL REQUIREMENTS

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

    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.

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:
Management / Supervisory
Function:
  Quality
Preferred Industry Background:
 
Managing a team of:
N/A
Required Travel:

Base Salary:
Confidential
Bonus:
Benefits:
Other Compensation: