Job Listing
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| Job ID: 14037013 |
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| Job Location: |
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| How to Apply: | To see employer contact information, log in or register. |
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| Job Title: | Supplier Quality Engineer |
| Work Type: | Work Days: Weekdays, Work Vary: No , Shift: First (Day), Hours Per Week: 40, Work Type: Regular |
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| Salary Offered: | Unspecified |
| Benefits: | 401(k) or other retirement, Dental Insurance, Health Insurance, Holidays, Vacation or PTO, Vision Plan |
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| Physical Required: | Yes |
| Drug Testing Required: | Yes |
| Education Required: | Bachelor's Degree |
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| Experience Required: | 6 Months |
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| Required Skills: | • Bachelor degree in Manufacturing Engineering or related field.
• At least 5+ years of Quality Engineering experience in medical device
• At least 2 years of experience specifically in Supplier Quality
• Blueprint reading is mandatory – GDNT level expected
• Experienced in Problem Solving methodologies and CAPA
• Experience qualifying, auditing and managing supplier in medical device
• Experience with validations (IQ,OQ,PQ)
• Experience conducting process capability, GR&R, PFMEA and SPC studies.
• Detailed knowledge of FDA, GMP, ISO 13485
• Solid communication and interpersonal skills, computer skills
• Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
• Multitasks, prioritizes and meets deadlines in timely manner.
• Strong organizational and follow-up skills, as well as attention to detail
• Ability to travel estimated up to 10% |
| Preferred Skills: | • Experience optimizing processes to achieve ongoing cost reductions.
• Experience in a precision machine shop environment.
• LEAN / Six Sigma training and demonstrated application.
• Experience in internal and supplier audits.
• Experience using an ERP system.
• Experience of managing a staff or cross functional team lead for senior position |
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| Driver's License: | None Required |
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| Job Description: |
Position Summary:
This position is responsible for assisting production, ensure that product and service from vendors and supplier are align with standards, managing the supplier performance and the CAPA/NCR linked to his/her scope of activities, leading Change Request, assuring compliance to and providing guidance regarding interpreting ISO 13485, FDA and applicable standards/requirements in link with the Supplier Quality Engineer activities.
The Supplier QE is working with the Manufacturing QE and QA Technicians and the Quality inspectors (QAR).
Key Responsibilities:
This position is primary responsible for:
1. Evaluates, investigates and communicates quality issues to suppliers and applies sound, systematic problem-solving methodologies in identifying, prioritizing, and resolving quality issues
2. Reviews and approves supplier corrective action plans and verification of effectiveness documentation
3. Coordinates the evaluation of proposed changes at suppliers
4. Plans and leads audits of suppliers to assess compliance with regulatory and Lisi Medical Remmele requirements, including audit scheduling investigation, and evaluation of audit observation and findings, reporting, follow-up
5. Proactively assesses supplier capabilities through direct on-site visits and technical discussions
6. Collaborate with cross-functional new product development teams to onboard suppliers
7. Generate and review quality plans, agreements, product specifications, component qualifications, design verification/validations, and process validations
8. Generates and maintains incoming inspection procedures
9. Assists in generating component specifications, Develops acceptance criteria for materials
10. Approve Supplier on the ASL and maintain accurate documentation related to supplier quality activities.
11. Lead and monitor Suppliers performance assessment
12. Statistical technics and 8D problem solving SME.
Refer to ID Supplier Quality Eng when applying |
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