Quality Engineer

Recruiter
Cpl Resources
Employment Type
Permanent
Salary
Not disclosed
Cpl Resources logo

The Quality Engineer conducts assignments encompassing complete projects or portions of major projects. They determine methods and techniques to be used or adapt standard methods to meet variations. They coordinate phases of work internally and externally.

The Quality Engineer will utilize Quality Engineering tools and practices for the effective and efficient development, transfer and maintenance of products/processes throughout the product lifecycle. The incumbent will also utilize Quality Engineering principles and problem-solving skills to improve and maintain products/processes that are aligned with the overall Quality and Business vision. He/she will utilize appropriate risk management to prevent unanticipated failure modes and improve capability of processes. This person will support processes in base business.

Major Responsibilities & Duties:

Business Improvements

• Support quality improvement initiatives such as process and product characterizations that lead to continuous / cost improvements.

• Review/analyze the effectiveness of PDCA, Six Sigma, Kaizen, Lean Techniques and/or other improvement tools and programs.

• Conduct benchmarking to develop more effective methods for improving quality

• Supports the development of quality engineering and quality compliance with the right skill sets for new product introductions, and product life cycle management.

Compliance/Regulatory

• Review/analyze whether current product and processes (including actions or decisions conducted) comply to standards such as the QSRs, ISO 13485, etc.

• Champions compliance to applicable Global Regulations and standards (e.g. QSRs, ISO, EN and Medical Device Directive (MDD) requirements) including providing support during internal and external audits.

• Conduct periodic line audits to assess for production controls such as lot segregation. Review results of area audits to ensure that corrective and preventive actions are adequate.

New Product/Process Introduction

• Partners with R&D and other cross functional partners to ensure the proper application of design controls, risk management and the investigation/correction of design failures/challenges.

• Supports new product introduction as part of design transfer.

Product Quality, Control & Disposition and Performance Standards

• Supports activities related to the Material Review Board.

• Conduct investigation, bounding, documentation, review and approval of non-conformances, CAPAs and customer complaints. Escalation of quality issues as appropriate.

• Accountability and ownership for material identification, material segregation, classification of defect types including the successful application of these techniques on a day-to-day basis in manufacturing.

• Analyze/review effectiveness of preventive and corrective actions. Review root cause investigation according to an established process.

• Accountability and ownership of Quality metrics including maintenance and reviewing of leading and lagging indicators of quality

Product/Process Qualification

• Approve IQ, OQ, PQ, TMV or Software Validation

Qualifications

• A minimum of a Bachelor’s Degree, preferably in Engineering or related technical field. Generally, requires 2-4 years related experience.

• Experience working in both an FDA and European regulatory environment is preferred.

• This position will require relevant experience working in manufacturing/operations.

• In-depth knowledge of product/process Risk Management (FDA and ISO standards) is required.

• Experience with a proven track record of implementing appropriate risk mitigation.

• Technical training and experience using Statistics, Lean and Six Sigma Methodologies is preferred including Measurement System Analysis, SPC, DOEs, Reliability, etc.

• Strong knowledge of statistical software packages is preferred with the ability to preview, graph and analyze data and be able to present data that facilitates/drives decision making.

• The ability to perform “hands on” troubleshooting and problem solving is preferred. The ability to think on the feet and providing sound judgment is highly desired.

• Good technical understanding of manufacturing equipment and processes is required.

• Understanding of the NPI (New Product Introduction) process and Process Validation expertise is preferred.