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Quality Audit Specialist

Job Description

The primary purpose of this job is to lead and facilitate the administration and continuous improvement of the site's quality system to ensure compliance with customer and regulatory requirements.
The primary purpose of this job is to lead and facilitate the administration and continuous improvement of the site's quality system to ensure compliance with customer and regulatory requirements.

  • Plans, conducts, tracks and coordinates internal and external audits.
  • Reviews and maintains corrective actions from audit findings.
  • Assist in the determination of root cause for the CAPA, and also the CAPA's investigation, implementation, and assessment of effectiveness
  • Reviews and edits documents and participates in the document change
  • Assists with quality assurance functions in support of needs directed by Quality Management.
  • Manage the timely response and closure of all audit observations and findings.
  • Provide metrics for audit status to management for Quality Management Reviews.
  • Provides Quality Systems training orientation to new Associates. Updates orientation materials as needed
  • Provides compliance guidance to Associates
  • Prepare, coordinate and document the sites Quality Management Review
  • Adheres to Integer Core Values and all safety and quality requirements including, but not limited to: Quality Management Systems (QMS), Environmental Management Systems (EMS), U.S. Food and Drug Administration (FDA) regulations, Company policies and operating procedures, and other regulatory requirements.
  • Performs other functions as required.

Minimum Education: Bachelor's degree in a related field strongly preferred.

Minimum Experience: 3-5 years within Quality Assurance and Compliance in the Medical Device, Pharmaceutical, or regulated industry.

Specialized Knowledge: Strong understanding of applicable regulations and standards (21 CFR 803, 806, and 820, and ISO 13485). Problem Solving and training skills.

Special Skills: Proficient in Microsoft Office applications required. Familiarity with eQMS Programs

Job Requirements

 

Job Snapshot

Location US-OR-Beaverton
Employment Type Full-Time
Pay Type Year
Pay Rate N/A
Store Type Engineering & Aerospace, Other
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Company Overview

Integer Holdings Corporation

Integer is committed to equal opportunity for all, without regard to race, color, religion, creed, national origin, ancestry, sex, age, physical or mental disability, veteran or military status, genetic information, sexual orientation, gender identity, marital status, or any other legally recognized protected basis under federal, state or local law. Greatbatch will make reasonable accommodations for known physical or mental limitations of otherwise qualified employees and applicants with disabilities unless the accommodation would impose an undue hardship on the operation of our business. If you are interested in applying for an employment opportunity and feel you need a reasonable accommodation pursuant to the ADA, please contact us at 716-759-5412. Learn More

Contact Information

US-OR-Beaverton
Rena Buckley
rbuckley@t.est.great
Snapshot
Integer Holdings Corporation
Company:
US-OR-Beaverton
Location:
Full-Time
Employment Type:
Year
Pay Type:
N/A
Pay Rate:
Engineering & Aerospace, Other
Store Type:

Job Description

The primary purpose of this job is to lead and facilitate the administration and continuous improvement of the site's quality system to ensure compliance with customer and regulatory requirements.
The primary purpose of this job is to lead and facilitate the administration and continuous improvement of the site's quality system to ensure compliance with customer and regulatory requirements.

  • Plans, conducts, tracks and coordinates internal and external audits.
  • Reviews and maintains corrective actions from audit findings.
  • Assist in the determination of root cause for the CAPA, and also the CAPA's investigation, implementation, and assessment of effectiveness
  • Reviews and edits documents and participates in the document change
  • Assists with quality assurance functions in support of needs directed by Quality Management.
  • Manage the timely response and closure of all audit observations and findings.
  • Provide metrics for audit status to management for Quality Management Reviews.
  • Provides Quality Systems training orientation to new Associates. Updates orientation materials as needed
  • Provides compliance guidance to Associates
  • Prepare, coordinate and document the sites Quality Management Review
  • Adheres to Integer Core Values and all safety and quality requirements including, but not limited to: Quality Management Systems (QMS), Environmental Management Systems (EMS), U.S. Food and Drug Administration (FDA) regulations, Company policies and operating procedures, and other regulatory requirements.
  • Performs other functions as required.

Minimum Education: Bachelor's degree in a related field strongly preferred.

Minimum Experience: 3-5 years within Quality Assurance and Compliance in the Medical Device, Pharmaceutical, or regulated industry.

Specialized Knowledge: Strong understanding of applicable regulations and standards (21 CFR 803, 806, and 820, and ISO 13485). Problem Solving and training skills.

Special Skills: Proficient in Microsoft Office applications required. Familiarity with eQMS Programs

Job Requirements

 
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