Quality Systems Specialist Wonderful Full Benefit Package

Website Berman Larson Kane

Best Technical Staffing Options since 1980

Quality Systems Specialist
City Parsippany
State NJ
Description  

Summary: The Quality Systems Specialist continually improves the Quality Management System through document change control, internal auditing, continual improvement, and record keeping. Has the responsibility to manage the document change control process and the SOP training records system. Responsible for performing internal audits and following up on audit related corrective actions and process improvement opportunities. Seeks synergies and efficiencies within QMS business practices and is a key support person during external audits.

Essential Duties & Responsibilities:

  • Administers the document change control process. Is a proficient user of Open Text (EDMS), manages change control records, prepares for Change Control Board meetings, and assures that all applicable document change procedures are followed.
  • Administers document training records (electronic and paper). Calculates training compliance metrics and communicates training needs to department heads. Working with department heads and HR, maintains current training needs documents for all job types within SNA.
  • Performs internal audits, and assesses the findings. Follows up on corrective actions when audit non-conformances are addressed. Assures compliance with SNA procedures, 21 CFR 820, SOR/98-282, and ISO 13485 through the audit process.
  • Tracks and reports actionable metrics for monitoring and improving the Quality Management System.
  • By observation and analysis of trends, recommends targets, investigates anomalies, etc. makes recommendations for improvements.
  • Supports the back-room operations during external audits/inspections (i.e. ISO 13485 Audits and FDA inspections). Provides objective evidence in a timely manner through applying knowledge of SNA QMS procedures and records.
  • Attends internal and external training, as required, to maintain auditor qualifications.
  • Performs Biennial document reviews. Updates SOPs as required through the change control process. Applies process-related thinking to improve QMS activities.
  • Performs other Quality Management duties as required.

Education and Requirements:

  • Bachelor’s Degree in Engineering, Science or related field required.
  • 2-4 years experience in a regulated industry (such as medical device, IVD, pharma, and/or aerospace) required. Prior knowledge of QSR and ISO 13485 a plus.
  • ASQ or similar professional certifications are a plus (e.g. CQA or CQE).
  • Travel Requirements- Up to 10% travel required.

Skills:

  • Demonstrated knowledge of quality systems, and good communication and analytical skills.
  • Ability to learn quickly and work with precision and accuracy.
  • Computer Skills – Proficiency in MS Office (especially Word, Excel, and Powerpoint). Ability to learn new applications quickly.

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