Quality Engineer (Compliance/Validation)

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Sterling-Hoffman Executive Search Located in: North Carolina,  North Carolina

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JOB DESCRIPTION

Partial Job Description

1) Ensure the site inspection readiness program is functioning and continuously improving

2) Follow-up and respond to 3rd party audit findings (i.e. FDA, ISO, customer, etc.)

3) Manage the Aging Records (CAPA, Complaints, Deviations, NCMR, Nonconformities) meeting with site and executive management ensuring key investigations are being completed on time and are adequate

4) Perform trending of quality systems to identify adverse trends and need for CAPA

5) Manage the backroom activities during FDA (government) inspections

6) Facilitate/host customer audits

7) Host 3rd party audits (FDA, ISO, Customer, etc.)

8) Coordinate collection of metrics/materials for semi-annual Quality System Management Review Meeting (QSMR)

9) Participate and lead project and investigation teams using quality tools such as Fishbone, 5 Why?s, Is/Is Not, etc.

CRITICAL REQUIREMENTS

  • Qualifications / Skills Required


    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 who have recent experience in Quality

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:
Experienced - Not Management
Function:
  Engineering
Preferred Industry Background:
 
Managing a team of:
N/A
Required Travel:

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