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Supplier Quality Engineering Manager

Job Description

The Supplier Quality Engineering Manager will be a part of our growing team in Irvine, CA. We are looking for a strong leader with solid technical expertise, who enjoys working in a fast paced and rapidly growing environment. The quality leader is responsible for overseeing qualification activities for suppliers and components being introduced as part of new product develop programs.

Job Function:

  • Provide oversight and mentorship for supplier quality engineers who are responsible for working with new product development teams and supplier development engineers on integrating new components and suppliers into the quality system.

  • Manage investigation, containment, and risk-based escalation (as appropriate) of nonconformance issues identified for purchased pre-commercial components.

  • Ensure supplier files associated with the suppliers utilized on new products comply with supplier qualification requirements.

  • Identify supplier quality engineering resource requirements and manage deployment of resources to provide coverage for the new product development programs.

  • Lead continuous improvement initiatives, including quality system and procedure adjustments, to elevate quality, compliance, and efficiency of the supplier qualification process.

  • Manage personnel ensuring growth and professional development.

Required Education & Skills:

  • A Bachelor's degree in engineering required; master's degree is preferred. Must have a minimum of 7 years of experience with comparable responsibilities and previous management experience required.

  • Must have a background in supplier quality or product development in medical devices.

  • Knowledge of the FDA's Quality System Regulations; experience working within a Quality Management System.

  • Ability to prioritize, plan & evaluate deliverables to established strategic goals.

  • Strong management and leadership skills to ensure management, growth and development of personnel.

  • Previous supervisory experience is required.

  • Excellent verbal and written communication and presentation skills with the ability to communicate business issues in an easy to understand manner.

  • Demonstrated experience prioritizing conflicting demands in an extremely fast paced environment.

  • Strong problem solving, influencing and negotiation skills, ability to work well as a leader, independently and in a team setting.

  • Strong working knowledge of Medical Device regulations, such as FDA 21 CFR 820, ISO 13485; MDD; CMDR; MDD 93/42/EEC and other applicable regulatory requirements.

  • ASQ Certified Quality Manager, Quality Engineer, Quality System Lead Auditor, or related quality/regulatory certifications a plus.

CB1

Job Requirements

Required Education & Skills:

A Bachelor's degree in engineering required; master's degree is preferred. Must have a minimum of 7 years of experience with comparable responsibilities and previous management experience required.
Must have a background in supplier quality or product development in medical devices.
Knowledge of the FDA's Quality System Regulations; experience working within a Quality Management System.
Ability to prioritize, plan & evaluate deliverables to established strategic goals.
Strong management and leadership skills to ensure management, growth and development of personnel.
Previous supervisory experience is required.

Job Snapshot

Location US-CA-Irvine
Employment Type Full-Time
Pay Type Year
Pay Rate $0.00 - $151,000.00 /Year
Store Type Engineering
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Company Overview

Yoh

Yoh is here. Yoh is there. Yoh is virtually everywhere. All in and busy going all out, doing everything it takes to take you where you want to go – forward. How? By foregoing the talent pool in favor of our own sea of talent, helping you find just the right person for the job. And if you think you're that person, we want to talk to you. Learn More

Contact Information

US-CA-Irvine
Yoh
Snapshot
Yoh
Company:
US-CA-Irvine
Location:
Full-Time
Employment Type:
Year
Pay Type:
$0.00 - $151,000.00 /Year
Pay Rate:
Engineering
Store Type:

Job Description

The Supplier Quality Engineering Manager will be a part of our growing team in Irvine, CA. We are looking for a strong leader with solid technical expertise, who enjoys working in a fast paced and rapidly growing environment. The quality leader is responsible for overseeing qualification activities for suppliers and components being introduced as part of new product develop programs.

Job Function:

  • Provide oversight and mentorship for supplier quality engineers who are responsible for working with new product development teams and supplier development engineers on integrating new components and suppliers into the quality system.

  • Manage investigation, containment, and risk-based escalation (as appropriate) of nonconformance issues identified for purchased pre-commercial components.

  • Ensure supplier files associated with the suppliers utilized on new products comply with supplier qualification requirements.

  • Identify supplier quality engineering resource requirements and manage deployment of resources to provide coverage for the new product development programs.

  • Lead continuous improvement initiatives, including quality system and procedure adjustments, to elevate quality, compliance, and efficiency of the supplier qualification process.

  • Manage personnel ensuring growth and professional development.

Required Education & Skills:

  • A Bachelor's degree in engineering required; master's degree is preferred. Must have a minimum of 7 years of experience with comparable responsibilities and previous management experience required.

  • Must have a background in supplier quality or product development in medical devices.

  • Knowledge of the FDA's Quality System Regulations; experience working within a Quality Management System.

  • Ability to prioritize, plan & evaluate deliverables to established strategic goals.

  • Strong management and leadership skills to ensure management, growth and development of personnel.

  • Previous supervisory experience is required.

  • Excellent verbal and written communication and presentation skills with the ability to communicate business issues in an easy to understand manner.

  • Demonstrated experience prioritizing conflicting demands in an extremely fast paced environment.

  • Strong problem solving, influencing and negotiation skills, ability to work well as a leader, independently and in a team setting.

  • Strong working knowledge of Medical Device regulations, such as FDA 21 CFR 820, ISO 13485; MDD; CMDR; MDD 93/42/EEC and other applicable regulatory requirements.

  • ASQ Certified Quality Manager, Quality Engineer, Quality System Lead Auditor, or related quality/regulatory certifications a plus.

CB1

Job Requirements

Required Education & Skills:

A Bachelor's degree in engineering required; master's degree is preferred. Must have a minimum of 7 years of experience with comparable responsibilities and previous management experience required.
Must have a background in supplier quality or product development in medical devices.
Knowledge of the FDA's Quality System Regulations; experience working within a Quality Management System.
Ability to prioritize, plan & evaluate deliverables to established strategic goals.
Strong management and leadership skills to ensure management, growth and development of personnel.
Previous supervisory experience is required.
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