The #1 Site for IT and Engineering Jobs - search all IT and Engineering  jobs.
Myq82k67jl0lwvf8xvn

Senior Quality Engineer

Job Description


The primary purpose of 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. This position may provide work direction for 3-5 Engineers / Technicians / Inspectors.
Key Accountabilities and Responsibilities
1. Adheres to Integer Core Beliefs 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.
2. Supports regulatory and agency inspections, audits, investigations, and inquiries regarding the control and assessment of product design and manufacturing quality.
3. Ability to interpret drawings, product/performance specifications, and other systems integration technical data
4. Monitors manufacturing of assigned products, assuring compliance with DMR and quality system requirements and assuring complete and correct Device History Records are maintained.
5. Leads product and process improvement initiatives.
6. Implements various product and process improvement methodologies
7. Reviews the adequacy and correctness of changes to Bill of Materials (BOM's), Assembly Procedures, Drawings, Component Specification, FMEAs, Control Plans, etc.
8. Leads in the development, completion, and maintenance of risk analyses.
9. Leads generation and completion of protocols and reports for product, process, and test method validations.
10. Interfaces with Manufacturing Engineers to review processes for new and existing products and coordinate process validations and capability studies. Recommends process monitoring devices where applicable.
11. Develops various inspection techniques and procedures to ensure product integrity to design specifications. Responsible for the writing, approval and implementation of Incoming, In-Process and Final Inspection procedures.
12. Ensures that the disposition of non-conforming materials meet all necessary regulatory requirements and assure adequacy of corrective actions to prevent re-occurrence.
13. Leads and manage complaint investigations and remediation recommendations as needed.
14. Leads plant CAPA activities, including analysis of data and trends in complaints, supplier quality, nonconforming material, training effectiveness, and root causes analysis.
15. Assists with product transfers.
16. Works with suppliers, management, Engineers and Manufacturing associates in the resolution of quality problems through capability studies and the application of statistical quality control which include Cpk, DOE, Hypotheses Testing, etc.
17. Provides technical support to and work direction other Quality Engineers as needed.
18. Performs other functions as required.

Job Requirements

 

Job Snapshot

Location US-MN-Chaska
Employment Type Full-Time
Pay Type Year
Pay Rate N/A
Store Type Engineering & Aerospace, Other
Apply

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-Chaska
Rena Buckley
Snapshot
Integer Holdings Corporation
Company:
US-MN-Chaska
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 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. This position may provide work direction for 3-5 Engineers / Technicians / Inspectors.
Key Accountabilities and Responsibilities
1. Adheres to Integer Core Beliefs 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.
2. Supports regulatory and agency inspections, audits, investigations, and inquiries regarding the control and assessment of product design and manufacturing quality.
3. Ability to interpret drawings, product/performance specifications, and other systems integration technical data
4. Monitors manufacturing of assigned products, assuring compliance with DMR and quality system requirements and assuring complete and correct Device History Records are maintained.
5. Leads product and process improvement initiatives.
6. Implements various product and process improvement methodologies
7. Reviews the adequacy and correctness of changes to Bill of Materials (BOM's), Assembly Procedures, Drawings, Component Specification, FMEAs, Control Plans, etc.
8. Leads in the development, completion, and maintenance of risk analyses.
9. Leads generation and completion of protocols and reports for product, process, and test method validations.
10. Interfaces with Manufacturing Engineers to review processes for new and existing products and coordinate process validations and capability studies. Recommends process monitoring devices where applicable.
11. Develops various inspection techniques and procedures to ensure product integrity to design specifications. Responsible for the writing, approval and implementation of Incoming, In-Process and Final Inspection procedures.
12. Ensures that the disposition of non-conforming materials meet all necessary regulatory requirements and assure adequacy of corrective actions to prevent re-occurrence.
13. Leads and manage complaint investigations and remediation recommendations as needed.
14. Leads plant CAPA activities, including analysis of data and trends in complaints, supplier quality, nonconforming material, training effectiveness, and root causes analysis.
15. Assists with product transfers.
16. Works with suppliers, management, Engineers and Manufacturing associates in the resolution of quality problems through capability studies and the application of statistical quality control which include Cpk, DOE, Hypotheses Testing, etc.
17. Provides technical support to and work direction other Quality Engineers as needed.
18. Performs other functions as required.

Job Requirements

 
Mwr1k875wzts0yxgjcl
Sologig Advice

For your privacy and protection, when applying to a job online: Never give your social security number to a prospective employer, provide credit card or bank account information, or perform any sort of monetary transaction.Learn More

By applying to a job using sologig.com you are agreeing to comply with and be subject to the workinretail.com Terms and Conditions for use of our website. To use our website, you must agree with theTerms & Conditionsand both meet and comply with their provisions.
Senior Quality Engineer Apply now