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Senior Quality 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.
Our Minneapolis facility is looking for a Senior Quality Engineer. This role will have the opportunity to interact with all levels of leadership, work on Continuous Improvement Projects and have the opportunity to mentor other engineers. This job is to provide support for Operations to ensure that the Quality System requirements are adhered to for medical device manufacturing/operations in accordance with applicable Regulatory and Standards requirements for compliance.

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.
  • Identifies and evaluates procedures to ensure the production of quality product.
  • Develops new and unique approaches to complex problems and can advance technology beyond previous achieved levels.
  • Applies engineering concepts to resolve acute or chronic problems.
  • Conducts studies to understand capability for process and/or measurement systems.
  • Provides management with technical guidance as required.
  • Identifies and develops appropriate documentation for process improvement and project implementation.
  • Maintains liaison with individuals and units within or outside the organization with responsibility for acting independently on technical matters pertaining to their filed.
  • 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: Bachelor's Degree in Engineering, Mathematics or Statistics required.

Minimum Experience: 7+ years' experience in medical device or regulated manufacturing

Specialized Knowledge: Competence in the selection and use of Quality Engineering Tools and Techniques.

Good knowledge in the interpretation and application of relevant Domestic and

International Regulations and Industry Standards (e.g. ISO, QSR, CFR, GxP, UL, MDD, TGA etc.)

Proficient in Microsoft Office and Minitab

Thorough knowledge and understanding of manufacturing quality requirements and solutions to obstacles that may impact successful transition at the component, subassembly, and final assembly levels

Special Skills:

Ability to work independently with minimal work direction and in a cross-functional team environment.

Ability to effectively communicate written and verbally.

Ability to manage time effectively to ensure timely completion of tasks.

Knowledge of SPC, FMEA, DOE, RCA, GDT

Sound knowledge of quality management systems.

Other: Certified Quality Engineering (CQE), Certified Software Quality Engineer (CSQE), Certified Reliability Engineer (CRE), Certified Quality Auditor (CQA), Certified Biomedical Auditor (CBA), or Six Sigma Green Belt or Black Belt desired

Job Requirements

 

Job Snapshot

Location US-MN-Minneapolis
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-MN-Minneapolis
Rena Buckley
rbuckley@t.est.greatbatchwd
Snapshot
Integer Holdings Corporation
Company:
US-MN-Minneapolis
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 manage engineering functions. Identify and evaluate procedures and process equipment required to produce a quality product.
Our Minneapolis facility is looking for a Senior Quality Engineer. This role will have the opportunity to interact with all levels of leadership, work on Continuous Improvement Projects and have the opportunity to mentor other engineers. This job is to provide support for Operations to ensure that the Quality System requirements are adhered to for medical device manufacturing/operations in accordance with applicable Regulatory and Standards requirements for compliance.

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.
  • Identifies and evaluates procedures to ensure the production of quality product.
  • Develops new and unique approaches to complex problems and can advance technology beyond previous achieved levels.
  • Applies engineering concepts to resolve acute or chronic problems.
  • Conducts studies to understand capability for process and/or measurement systems.
  • Provides management with technical guidance as required.
  • Identifies and develops appropriate documentation for process improvement and project implementation.
  • Maintains liaison with individuals and units within or outside the organization with responsibility for acting independently on technical matters pertaining to their filed.
  • 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: Bachelor's Degree in Engineering, Mathematics or Statistics required.

Minimum Experience: 7+ years' experience in medical device or regulated manufacturing

Specialized Knowledge: Competence in the selection and use of Quality Engineering Tools and Techniques.

Good knowledge in the interpretation and application of relevant Domestic and

International Regulations and Industry Standards (e.g. ISO, QSR, CFR, GxP, UL, MDD, TGA etc.)

Proficient in Microsoft Office and Minitab

Thorough knowledge and understanding of manufacturing quality requirements and solutions to obstacles that may impact successful transition at the component, subassembly, and final assembly levels

Special Skills:

Ability to work independently with minimal work direction and in a cross-functional team environment.

Ability to effectively communicate written and verbally.

Ability to manage time effectively to ensure timely completion of tasks.

Knowledge of SPC, FMEA, DOE, RCA, GDT

Sound knowledge of quality management systems.

Other: Certified Quality Engineering (CQE), Certified Software Quality Engineer (CSQE), Certified Reliability Engineer (CRE), Certified Quality Auditor (CQA), Certified Biomedical Auditor (CBA), or Six Sigma Green Belt or Black Belt desired

Job Requirements

 
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