Quality Engineer - LanceSoft Inc
Durham, NC 27703
About the Job
Work days/hours: M - F 8am - 5pm
Pay $51.18/hr
Onsite daily
LOCALS ONLY
Reporting into the Supplier Quality organization, this position supports all efforts in developing and management for all Durham, NC facility. Primary responsibility for this position includes ensuring suppliers are compliant with Client standards and applicable US & global regulatory requirements as well as ensuring supplier has capacity and capability to meet Client demand. This position is accountable to provide leadership, development and coaching to suppliers as well as internal Supplier Quality Engineers.
This position partners with internal stakeholders to ensure compliance to product, customer, and regulatory expectations.
Key areas of focus within supplier management are leading supplier & process qualifications, leading issue/defect resolution, managing performance monitoring/reporting, compliance to appropriate standards, and streamlining/developing processes.
Key areas of support provided to team members include management of non-conformances, risk management/ communication, defect resolution, process capability/process improvement, and quality assurance general support.
Adheres to environmental policy, procedures, and supports department environmental objective.
1. Drives supplier qualification/approval process by assessing supplier QMS as well as manufacturing and technology capabilities through onsite and virtual audit activities
2. Supports design, development, and manufacturing operations toward resolution of supplier quality problems as well as the implementation of corrections and corrective actions
3. Works with suppliers to establish and maintain robust/rigorous measurement methodologies
4. Partners with suppliers to establish and maintain controlled manufacturing processes
5. Ability to collaborate externally with suppliers as well as internally with Quality, Operations, Supply Chain, Procurement and Engineering.
6. Performs root cause analysis and corrective actions for supplier quality issues (SCARs)
7. Performs supplier validation activities using Advanced Product Quality Planning (APQP)
8. Performs supplier Production Part Approval Process (PPAP) activities
9. Supports the reporting of supplier quality trends, performance, and other information to leadership
10. Travel up to 25% may be required
11. Support and subsequently implements assigned Quality Plans
12. Supports and if needed owns Corrective Action and Preventive Action (CAPA) projects and implements relative action items
13. Performs techniques for continuous improvement such as Lean, Six-Sigma, Poka-Yoke (Error Proofing), Measurement System Analysis and FMEA (Failure Mode and Effects Analysis)
14. Partners with suppliers to establish and maintain controlled manufacturing processes
15. Other duties and responsibilities as assigned.
16. Supports audit, Internal and External
17. Partners with suppliers to establish and maintain controlled on Supplier imposed changes
Minimum Experience:
1. Bachelor's degree in an engineering discipline is required
2. A minimum of 5 year’s total experience in a Quality or Supplier Quality engineering role is required. A minimum or 3 years in Supplier Quality role desired
3. Prior experience within a regulated industry (e.g., medical device, pharma, Automotive, Aerospace) is required
4. Lead Auditor certification is required
5. CAPA experience- Candidate must have worked and performed root cause analysis.
6. Design Controls- Candidate to have experience in working with Design Controls either in an NPI or Operations setting
7. Demonstrated knowledge of the Quality Engineering body of knowledge is required
8. Good communication and strong writing skills are required
9. Expertise with PCB, PCBA, or electro-mechanical assemblies is a plus.
10. ASQ certifications are a plus (CQE, CRE, CSQE, Six Sigma, CMDA, CQA)
11. Demonstrated knowledge of DMAIC\Six Sigma and problem-solving methodologies is a required
12. Candidate must be able to work autonomously and independently
13. Working knowledge of any of these standards desired: 21CFR part 820 (QSR), ISO13485, ISO/TR 24971:2020, IEC 60601-1, IEC 62304, IEC 623666-1, ISO 10993-1
Knowledge, Skills, and Abilities Requirements
• Strong negotiating, influence, and leadership abilities
• Strong communication skills. Ability to communicate clearly and efficiently during difficult situations
• Ability to work in a team environment and work through others
• Strong analytical & problem-solving skills
• Ability to build and maintain a team and to work in a matrix organization
• Ability to define a project and direct teams through execution
• Action oriented when facing issue, change and uncertainty
• Use data to drive decision making process
Pay $51.18/hr
Onsite daily
LOCALS ONLY
Reporting into the Supplier Quality organization, this position supports all efforts in developing and management for all Durham, NC facility. Primary responsibility for this position includes ensuring suppliers are compliant with Client standards and applicable US & global regulatory requirements as well as ensuring supplier has capacity and capability to meet Client demand. This position is accountable to provide leadership, development and coaching to suppliers as well as internal Supplier Quality Engineers.
This position partners with internal stakeholders to ensure compliance to product, customer, and regulatory expectations.
Key areas of focus within supplier management are leading supplier & process qualifications, leading issue/defect resolution, managing performance monitoring/reporting, compliance to appropriate standards, and streamlining/developing processes.
Key areas of support provided to team members include management of non-conformances, risk management/ communication, defect resolution, process capability/process improvement, and quality assurance general support.
Adheres to environmental policy, procedures, and supports department environmental objective.
1. Drives supplier qualification/approval process by assessing supplier QMS as well as manufacturing and technology capabilities through onsite and virtual audit activities
2. Supports design, development, and manufacturing operations toward resolution of supplier quality problems as well as the implementation of corrections and corrective actions
3. Works with suppliers to establish and maintain robust/rigorous measurement methodologies
4. Partners with suppliers to establish and maintain controlled manufacturing processes
5. Ability to collaborate externally with suppliers as well as internally with Quality, Operations, Supply Chain, Procurement and Engineering.
6. Performs root cause analysis and corrective actions for supplier quality issues (SCARs)
7. Performs supplier validation activities using Advanced Product Quality Planning (APQP)
8. Performs supplier Production Part Approval Process (PPAP) activities
9. Supports the reporting of supplier quality trends, performance, and other information to leadership
10. Travel up to 25% may be required
11. Support and subsequently implements assigned Quality Plans
12. Supports and if needed owns Corrective Action and Preventive Action (CAPA) projects and implements relative action items
13. Performs techniques for continuous improvement such as Lean, Six-Sigma, Poka-Yoke (Error Proofing), Measurement System Analysis and FMEA (Failure Mode and Effects Analysis)
14. Partners with suppliers to establish and maintain controlled manufacturing processes
15. Other duties and responsibilities as assigned.
16. Supports audit, Internal and External
17. Partners with suppliers to establish and maintain controlled on Supplier imposed changes
Minimum Experience:
1. Bachelor's degree in an engineering discipline is required
2. A minimum of 5 year’s total experience in a Quality or Supplier Quality engineering role is required. A minimum or 3 years in Supplier Quality role desired
3. Prior experience within a regulated industry (e.g., medical device, pharma, Automotive, Aerospace) is required
4. Lead Auditor certification is required
5. CAPA experience- Candidate must have worked and performed root cause analysis.
6. Design Controls- Candidate to have experience in working with Design Controls either in an NPI or Operations setting
7. Demonstrated knowledge of the Quality Engineering body of knowledge is required
8. Good communication and strong writing skills are required
9. Expertise with PCB, PCBA, or electro-mechanical assemblies is a plus.
10. ASQ certifications are a plus (CQE, CRE, CSQE, Six Sigma, CMDA, CQA)
11. Demonstrated knowledge of DMAIC\Six Sigma and problem-solving methodologies is a required
12. Candidate must be able to work autonomously and independently
13. Working knowledge of any of these standards desired: 21CFR part 820 (QSR), ISO13485, ISO/TR 24971:2020, IEC 60601-1, IEC 62304, IEC 623666-1, ISO 10993-1
Knowledge, Skills, and Abilities Requirements
• Strong negotiating, influence, and leadership abilities
• Strong communication skills. Ability to communicate clearly and efficiently during difficult situations
• Ability to work in a team environment and work through others
• Strong analytical & problem-solving skills
• Ability to build and maintain a team and to work in a matrix organization
• Ability to define a project and direct teams through execution
• Action oriented when facing issue, change and uncertainty
• Use data to drive decision making process
Source : LanceSoft Inc
