Quality Engineer

Title: Engr 1, Quality

Location: Durham, NC, USA, 27703

Duration: 05/24/2024 to 05/23/2025 (12 Months)

Position: Onsite

Shift Timings: M - F 8am - 5pm

Job Description:

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.

Drives supplier qualification/approval process by assessing supplier QMS as well as manufacturing and technology capabilities through onsite and virtual audit activities

Supports design, development, and manufacturing operations toward resolution of supplier quality problems as well as the implementation of corrections and corrective actions

Works with suppliers to establish and maintain robust/rigorous measurement methodologies

Partners with suppliers to establish and maintain controlled manufacturing processes

Ability to collaborate externally with suppliers as well as internally with Quality, Operations, Supply Chain, Procurement and Engineering.

Performs root cause analysis and corrective actions for supplier quality issues (SCARs)

Performs supplier validation activities using Advanced Product Quality Planning (APQP)

Performs supplier Production Part Approval Process (PPAP) activities

Supports the reporting of supplier quality trends, performance, and other information to leadership

Travel up to 25% may be required

Support and subsequently implements assigned Quality Plans

Supports and if needed owns Corrective Action and Preventive Action (CAPA) projects and implements relative action items

Performs techniques for continuous improvement such as Lean, Six-Sigma, Poka-Yoke (Error Proofing), Measurement System Analysis and FMEA (Failure Mode and Effects Analysis)

Partners with suppliers to establish and maintain controlled manufacturing processes

Other duties and responsibilities as assigned.

Supports audit, Internal and External

Partners with suppliers to establish and maintain controlled on Supplier imposed changes

Minimum Experience:

Bachelor's degree in an engineering discipline is required

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

Prior experience within a regulated industry (e.g., medical device, pharma, Automotive, Aerospace) is required

Lead Auditor certification is required

CAPA experience- Candidate must have worked and performed root cause analysis.

Design Controls- Candidate to have experience in working with Design Controls either in an NPI or Operations setting

Demonstrated knowledge of the Quality Engineering body of knowledge is required

Good communication and strong writing skills are required

Expertise with PCB, PCBA, or electro-mechanical assemblies is a plus.

ASQ certifications are a plus (CQE, CRE, CSQE, Six Sigma, CMDA, CQA)

Demonstrated knowledge of DMAIC\Six Sigma and problem-solving methodologies is a required

Candidate must be able to work autonomously and independently

Working knowledge of any of these standards desired: 21CFR part 820 (QSR), ISO13485, ISO/TR 24971:2020, IEC (phone number removed), IEC 62304, IEC (phone number removed), ISO (phone number removed)

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