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Senior Quality Systems Engineer

Job Description

The primary purpose of this job is to manage engineering functions. Identify and evaluate procedures and process equipment required to produce a quality product.

  • Do you have a passion for quality systems?
  • Are you looking to join one of the top medical device quality organizations?
  • Are you a natural problem solver?



If you answered yes, we'd love to speak with you. Integer is hiring for a Senior Quality Systems Engineer.



Accountabilities & Responsibilities:

  • Adheres to Integer's Values and all safety, environmental, security and quality requirements including, but not limited to: Quality Management Systems (QMS), Safety, Environmental and Security Management Systems, U.S. Food and Drug Administration (FDA) regulations, company policies and operating procedures, and other regulatory requirements.
  • Leads the execution and improvement of quality assurance and quality systems activities.
  • Develops and manages quality systems that comply with national and global regulatory requirements.
  • May lead and conduct detailed quality analyses including cost of quality trends and root cause analyses.
  • Develops new and unique approaches to complex problems and advance technology beyond previous company involvement.
  • Plans/develops engineering projects concerned with unique or high-profile problems which have important effect on major organization programs.
  • Provides management with technical guidance as required.
  • Identifies and procures the appropriate process equipment.
  • Investigates, develops and implements new process technologies of major scope.
  • Maintains liaison with individuals and business units within or outside his/her organization with responsibility for acting independently on technical matters pertaining to his/her field.
  • Subject matter expert in engineering specialty/application.
  • Performs other duties as required.



Minimum Education & Experience:

  • Bachelor's degree required (technical discipline preferred)
  • 7+ years Quality Assurance and Compliance in the Medical Device, Pharmaceutical, or Diagnostics 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 (TrackWise, EtQ, etc.) desired.

Job Requirements

 

Job Snapshot

Location US-MA-Wilmington
Employment Type Full-Time
Pay Type Year
Pay Rate N/A
Store Type 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-MA-Wilmington
Steve Marshall
Snapshot
Integer Holdings Corporation
Company:
US-MA-Wilmington
Location:
Full-Time
Employment Type:
Year
Pay Type:
N/A
Pay Rate:
Other
Store Type:

Job Description

The primary purpose of this job is to manage engineering functions. Identify and evaluate procedures and process equipment required to produce a quality product.

  • Do you have a passion for quality systems?
  • Are you looking to join one of the top medical device quality organizations?
  • Are you a natural problem solver?



If you answered yes, we'd love to speak with you. Integer is hiring for a Senior Quality Systems Engineer.



Accountabilities & Responsibilities:

  • Adheres to Integer's Values and all safety, environmental, security and quality requirements including, but not limited to: Quality Management Systems (QMS), Safety, Environmental and Security Management Systems, U.S. Food and Drug Administration (FDA) regulations, company policies and operating procedures, and other regulatory requirements.
  • Leads the execution and improvement of quality assurance and quality systems activities.
  • Develops and manages quality systems that comply with national and global regulatory requirements.
  • May lead and conduct detailed quality analyses including cost of quality trends and root cause analyses.
  • Develops new and unique approaches to complex problems and advance technology beyond previous company involvement.
  • Plans/develops engineering projects concerned with unique or high-profile problems which have important effect on major organization programs.
  • Provides management with technical guidance as required.
  • Identifies and procures the appropriate process equipment.
  • Investigates, develops and implements new process technologies of major scope.
  • Maintains liaison with individuals and business units within or outside his/her organization with responsibility for acting independently on technical matters pertaining to his/her field.
  • Subject matter expert in engineering specialty/application.
  • Performs other duties as required.



Minimum Education & Experience:

  • Bachelor's degree required (technical discipline preferred)
  • 7+ years Quality Assurance and Compliance in the Medical Device, Pharmaceutical, or Diagnostics 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 (TrackWise, EtQ, etc.) desired.

Job Requirements

 
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