Quality System Engineer

What Youll Work On

• Analyze Quality System data and present established metrics to management.
• Investigates and resolves quality system corrective actions and preventive actions.
• Support internal and external audits.
• Works with cross functional teams to develop sound quality improvement plans that effectively consider the impact of change(s) and the actions required for implementation.
• Ensures compliance to ISOCFR 820 Quality System Regulations and other applicable regulations and standards by providing support for interpretation of regulations performing gap analysis and leading activities to implement improvements.
• Apply sound systematic problem-solving methodologies in identifying prioritizing communicating and resolving quality issues.
• As appropriate utilizes Lean Six Sigma and other quality tools to implement process improvements to enhance product quality and reduce process variance by identifying improvement opportunities in divisional quality system compliance device and process.
• Analyzes quality audit findings and recommends modifications in products and processes. Proactively identifies opportunities for system compliance improvement and leads activities to implement improvements.

Required Qualifications

• Bachelors Degree in Engineering or Technical Degree or an equivalent combination of education and work experience.
• 3 years experience in the ownership of CAPA process to include conducting root cause investigations and developing action plans/effectiveness checks.

Preferred Qualifications

• Demonstrated and impactful project management and leadership skills including the demonstrated ability to lead multi-departmental project teams and resolve quality system-related issues in a timely and effective manner.
• Multitasks prioritizes and meets deadlines in timely manner.
• Strong organizational and follow-up skills as well as attention to detail.
• Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
• Experience working in a broader enterprise/cross-division business unit model preferred.
• Ability to work within a team and as an individual contributor in a fast-paced changing environment.
• Advanced computer skills including gap analysis and report writing skills.
• Detailed knowledge of FDA GMP and ISO 13485.

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The base pay for this position is

In specific locations the pay range may vary from the range posted.

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