Quality Engineer

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Quality Analyst

Quality Analyst

Job Description


The Role:

Our quality analyst will collaborate with the team to monitor and enhance the quality of our processes and outcomes. You will be accountable for creating quality standards, building quality control systems, and leading cross-functional teams in problem-solving, thereby producing ingenious, effective corrective actions.

An excellent quality analyst should be an exceptional problem solver and meticulous in ensuring that our processes and products consistently meet both customer requirements and all regulatory standards.

Quality Analyst Responsibilities:

· Creating and implementing quality standards and systems

Monitoring and evaluating quality performance and possessing a working knowledge of statistical controls.

· Possessing a working knowledge of Regulatory Requirements: IS013485, AS9100, ITAR, 21 CFR Part 11, REACH/RoHS, CMRT,

· Possessing a working knowledge of Quality Tools: 5why, fishbone, APQP, PPAP, PFMEA, SPC, MSA,

· Collaborating with operations to develop and implement controls and improvements.

· Ensuring that workflows, processes, and products comply with customer and regulatory requirements.

· Leading the investigation and troubleshooting of product or production issues.

· Driving corrective action efforts, solutions, and continual improvements.

· Acting as the point of contact for customer quality issues and being responsible for scorecard feedback on quality.

· Conducting customer audits, internal audits, and assisting with external audits.

· Handling supplier issues, including issuing Supplier Corrective Actions and ensuring follow-through.

· Representing quality at MRB and Product Launches for NPI.

· Ensuring document control is maintained.

Quality Analyst Requirements:

· Minimum of 5+ years of experience in Quality Engineering within the medical manufacturing industry.

· Bachelor’s degree in engineering (or a related technical field) is required.

· Must hold an active ISO13485 Lead auditor certificate.

· Strong working knowledge of GD&T is required.

· Proficiency in Microsoft Word, Excel, and PowerPoint is necessary.

· Excellent communication and interpersonal skills are required.

· Must have strong analytical and problem-solving skills.

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