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Sr. Supplier quality Engineer

Job Description



Description

As our Supplier Quality Engineer you will be  responsible for overseeing the incoming quality of materials delivered to Medical which includes evaluating suppliers, resolving supplier quality issues, and overseeing the Supplier Corrective Action program.Your experience and expertise will enable you to:

1. Develop and execute audit plans for all relevant suppliers in compliance with Medicals Supplier Qualification program.
2. Carry out onsite Supplier audits, report and follow up on audit results including any non-conformances.
3. Provide quality engineering support to new product development teams and Supply Chain Management.
4. Identify, initiate and follow through of Supplier Corrective Action Reports (SCAR) to ensure effective corrective/preventive actions are implemented.
5. Lead review meetings and provide and analyze key metrics.  Submit trends for possible Corrective and Preventive Actions.
6. Assist with the calibration and verification of tools and equipment when needed.
7. Write, review and/or approve product drawings/specifications, test protocol/reports, and inspection processes.
8. Devise and execute experimental studies, including GD&T, Gage R&R, tolerance stack ups, etc.
9. Work with supplier to help improve process capabilities, including providing input into process validation activities, such as IQ, OQ and PQ requirements.
10. Develop supplier quality plans using risk based assessments to determine inspection requirements and acceptance criteria.
11. Participate and/or lead Material Review Boards (MRB) to ensure that non-conforming product is properly investigated and dispositioned.  Work with the supplier to correct non-conformances.
12. Conduct Corrective and Preventive Action activities to investigate causes of non-conformance, determine root cause and implement corrective actions to eliminate quality problems.
13. Provides guidance and oversight to maintain the RoHS progam.
14. Create, implement and teach new quality systems as required.
 

Minimum Requirements
1. BS degree in Engineering discipline or equivalent degree + experience
2. Minimum of  eight years’ experience in engineering related industry, of which 5 years should be in the medical device industry.
3. Direct experience with FDA QSR and ISO 13485 compliance.
4. Knowledge of development, validation and manufacture of medical devices.
5. Experience with electro-mechanical equipment recommended.
6. Quality Systems Lead Auditor certification required.
7. Must be willing and available to travel frequently to various supplier sites.

Job Requirements



Description

As our Supplier Quality Engineer you will be  responsible for overseeing the incoming quality of materials delivered to Medical which includes evaluating suppliers, resolving supplier quality issues, and overseeing the Supplier Corrective Action program.Your experience and expertise will enable you to:

1. Develop and execute audit plans for all relevant suppliers in compliance with Medicals Supplier Qualification program.
2. Carry out onsite Supplier audits, report and follow up on audit results including any non-conformances.
3. Provide quality engineering support to new product development teams and Supply Chain Management.
4. Identify, initiate and follow through of Supplier Corrective Action Reports (SCAR) to ensure effective corrective/preventive actions are implemented.
5. Lead review meetings and provide and analyze key metrics.  Submit trends for possible Corrective and Preventive Actions.
6. Assist with the calibration and verification of tools and equipment when needed.
7. Write, review and/or approve product drawings/specifications, test protocol/reports, and inspection processes.
8. Devise and execute experimental studies, including GD&T, Gage R&R, tolerance stack ups, etc.
9. Work with supplier to help improve process capabilities, including providing input into process validation activities, such as IQ, OQ and PQ requirements.
10. Develop supplier quality plans using risk based assessments to determine inspection requirements and acceptance criteria.
11. Participate and/or lead Material Review Boards (MRB) to ensure that non-conforming product is properly investigated and dispositioned.  Work with the supplier to correct non-conformances.
12. Conduct Corrective and Preventive Action activities to investigate causes of non-conformance, determine root cause and implement corrective actions to eliminate quality problems.
13. Provides guidance and oversight to maintain the RoHS progam.
14. Create, implement and teach new quality systems as required.
 

Minimum Requirements
1. BS degree in Engineering discipline or equivalent degree + experience
2. Minimum of  eight years’ experience in engineering related industry, of which 5 years should be in the medical device industry.
3. Direct experience with FDA QSR and ISO 13485 compliance.
4. Knowledge of development, validation and manufacture of medical devices.
5. Experience with electro-mechanical equipment recommended.
6. Quality Systems Lead Auditor certification required.
7. Must be willing and available to travel frequently to various supplier sites.

Job Snapshot

Location US-WA-Seattle
Employment Type Full-Time
Pay Type Year
Pay Rate N/A
Store Type Engineering & Aerospace
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Company Overview

American Cybersystems, Inc. (ACS Group)

ACS Group provides services to Fortune 1000 companies across various industry verticals. With a proven track record of managing project demands while improving the efficiency, productivity and profitability of new and existing projects through process improvement, ACS Group is consistently recognized for identifying and implementing strategic solutions that create and preserve long-term business value. Learn More

Contact Information

US-WA-Seattle
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Snapshot
American Cybersystems, Inc. (ACS Group)
Company:
US-WA-Seattle
Location:
Full-Time
Employment Type:
Year
Pay Type:
N/A
Pay Rate:
Engineering & Aerospace
Store Type:

Job Description



Description

As our Supplier Quality Engineer you will be  responsible for overseeing the incoming quality of materials delivered to Medical which includes evaluating suppliers, resolving supplier quality issues, and overseeing the Supplier Corrective Action program.Your experience and expertise will enable you to:

1. Develop and execute audit plans for all relevant suppliers in compliance with Medicals Supplier Qualification program.
2. Carry out onsite Supplier audits, report and follow up on audit results including any non-conformances.
3. Provide quality engineering support to new product development teams and Supply Chain Management.
4. Identify, initiate and follow through of Supplier Corrective Action Reports (SCAR) to ensure effective corrective/preventive actions are implemented.
5. Lead review meetings and provide and analyze key metrics.  Submit trends for possible Corrective and Preventive Actions.
6. Assist with the calibration and verification of tools and equipment when needed.
7. Write, review and/or approve product drawings/specifications, test protocol/reports, and inspection processes.
8. Devise and execute experimental studies, including GD&T, Gage R&R, tolerance stack ups, etc.
9. Work with supplier to help improve process capabilities, including providing input into process validation activities, such as IQ, OQ and PQ requirements.
10. Develop supplier quality plans using risk based assessments to determine inspection requirements and acceptance criteria.
11. Participate and/or lead Material Review Boards (MRB) to ensure that non-conforming product is properly investigated and dispositioned.  Work with the supplier to correct non-conformances.
12. Conduct Corrective and Preventive Action activities to investigate causes of non-conformance, determine root cause and implement corrective actions to eliminate quality problems.
13. Provides guidance and oversight to maintain the RoHS progam.
14. Create, implement and teach new quality systems as required.
 

Minimum Requirements
1. BS degree in Engineering discipline or equivalent degree + experience
2. Minimum of  eight years’ experience in engineering related industry, of which 5 years should be in the medical device industry.
3. Direct experience with FDA QSR and ISO 13485 compliance.
4. Knowledge of development, validation and manufacture of medical devices.
5. Experience with electro-mechanical equipment recommended.
6. Quality Systems Lead Auditor certification required.
7. Must be willing and available to travel frequently to various supplier sites.

Job Requirements



Description

As our Supplier Quality Engineer you will be  responsible for overseeing the incoming quality of materials delivered to Medical which includes evaluating suppliers, resolving supplier quality issues, and overseeing the Supplier Corrective Action program.Your experience and expertise will enable you to:

1. Develop and execute audit plans for all relevant suppliers in compliance with Medicals Supplier Qualification program.
2. Carry out onsite Supplier audits, report and follow up on audit results including any non-conformances.
3. Provide quality engineering support to new product development teams and Supply Chain Management.
4. Identify, initiate and follow through of Supplier Corrective Action Reports (SCAR) to ensure effective corrective/preventive actions are implemented.
5. Lead review meetings and provide and analyze key metrics.  Submit trends for possible Corrective and Preventive Actions.
6. Assist with the calibration and verification of tools and equipment when needed.
7. Write, review and/or approve product drawings/specifications, test protocol/reports, and inspection processes.
8. Devise and execute experimental studies, including GD&T, Gage R&R, tolerance stack ups, etc.
9. Work with supplier to help improve process capabilities, including providing input into process validation activities, such as IQ, OQ and PQ requirements.
10. Develop supplier quality plans using risk based assessments to determine inspection requirements and acceptance criteria.
11. Participate and/or lead Material Review Boards (MRB) to ensure that non-conforming product is properly investigated and dispositioned.  Work with the supplier to correct non-conformances.
12. Conduct Corrective and Preventive Action activities to investigate causes of non-conformance, determine root cause and implement corrective actions to eliminate quality problems.
13. Provides guidance and oversight to maintain the RoHS progam.
14. Create, implement and teach new quality systems as required.
 

Minimum Requirements
1. BS degree in Engineering discipline or equivalent degree + experience
2. Minimum of  eight years’ experience in engineering related industry, of which 5 years should be in the medical device industry.
3. Direct experience with FDA QSR and ISO 13485 compliance.
4. Knowledge of development, validation and manufacture of medical devices.
5. Experience with electro-mechanical equipment recommended.
6. Quality Systems Lead Auditor certification required.
7. Must be willing and available to travel frequently to various supplier sites.

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