Recent Searches

You haven't searched anything yet.

1 Quality Compliance & Audit Specialist-Medical Devices Job in Parsippany, NJ

SET JOB ALERT
Details...
Diagnostica Stago Inc.
Parsippany, NJ | Full Time
$137k-175k (estimate)
0 Months Ago
Quality Compliance & Audit Specialist-Medical Devices
$137k-175k (estimate)
Full Time 0 Months Ago
Save

sadSorry! This job is no longer available. Please explore similar jobs listed on the left.

Diagnostica Stago Inc. is Hiring a Quality Compliance & Audit Specialist-Medical Devices Near Parsippany, NJ

Job Category: Regulatory and Quality Affairs
Requisition Number: QUALI002781

Apply now

Posting Details
      Posted: March 28, 2023

    Full-Time

    Locations
    Showing 1 location

    DSI Main Office
    Parsippany, NJ 07054, USA

Job Details

Description

Summary:

The Compliance and Audit Specialist plays a pivotal role in continuously monitoring and improving the Quality Management System through leading projects, auditing, reporting metrics, and implementing industry best practices. Among other duties, they manage the internal audit program, lead QMS projects, perform internal and supplier audits, interact with regulators and auditing organizations, support CAPA investigations, write procedures, present data to all levels of the organization, act as a trainer, and are proficient users of several software platforms. The Compliance and Audit Specialist is SNA's Deputy Management Representative.

Essential Duties & Responsibilities:

  • Acts as the Deputy Management Representative in the Director's absence.
  • Acts as ISO 13485 SME. Leads teams that will make significant improvements, changes, and additions to the QMS.
  • Manages QMS projects and influences cross-functional team members.
  • Manages the internal audit program. Trains new auditors. Applies independent judgment to developing audit plans, administering internal audits, and assessing the findings. Applies risk-based thinking to audit findings,and recommends risk-reducing corrective actions when audit non-conformities are identified. Assures compliance with SNA procedures, 21 CFR 820, SOR/98-282, and ISO 13485 through the internal audit program. Follows up on audit-related corrective actions.
  • Develops, improves, tracks, and reports meaningful and actionable metrics for the Management Review Process.
  • Determines when actions are required and makes recommendations for procedural improvements. Determines if CAPA actions are required.
  • Helps facilitate third party audits and inspections by representing Stago North America with face-to-face interaction with regulators and auditors in the audit Front Room.
  • Is a highly proficient user of key systems (e.g. CRM, Open Text, Intraqual Dynamic). Identifies opportunities for improvement and makes recommendations to the Data Management teams in Headquarters.
  • Maintains knowledge and training required to perform internal audits. Trains other internal auditors.
  • Performs supplier reviews and supplier audits as necessary and appropriate.
  • Leads annual process reviews to assure that risk management documents remain current. Reports the outcome to upper management as part of the Management Review Process.
  • Delivers training and presents data and project status information to all levels of the organization.
  • Attends monthly validation meetings with HQ.
  • Prepares data package for Management Review Meetings.
  • Performs other Quality Management duties as required.

Education and/or Experience:

  • Bachelor’s degree in Engineering, Science, or related field required (Master’s degree preferred).
  • Three to Five years progressive experience in medical device quality or quality management systems required (or Master’s degree 3 Years' experience).
  • Demonstrated proficiency in internal and/or external QMS auditing.
  • Knowledge in medical device and FDA Regulations is required. ISO 13485 experience is preferred.
  • Proficiency in MS Office (especially Word, Excel, Project, and Powerpoint). Demonstrated ability to analyze and present Key Performance Indicators. Ability to learn new applications quickly.
  • ASQ (or similar) professional certifications a plus (e.g. Certified Quality Engineer or Auditor).
  • Up to 10% travel required.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, citizenship, disability or protected veteran status.

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c)

Job Summary

JOB TYPE

Full Time

SALARY

$137k-175k (estimate)

POST DATE

03/30/2023

EXPIRATION DATE

12/03/2023

WEBSITE

stago-us.com

HEADQUARTERS

BUDD LAKE, NJ

SIZE

1,000 - 3,000

FOUNDED

1976

REVENUE

$200M - $500M

Show more

Diagnostica Stago Inc.
Full Time
$96k-124k (estimate)
7 Days Ago
Diagnostica Stago Inc.
Full Time
$80k-99k (estimate)
2 Weeks Ago
Diagnostica Stago Inc.
Full Time
$76k-94k (estimate)
2 Weeks Ago