Sr. Quality Assurance Engineer

Description

The company has been in business for over 179 years.

It is a global company with over 42,000 employees, more than 4,000 of them in the US and Canada.

Its segments are Industrial Quality & Research, Medical Technology, Consumer Markets and Semiconductor Manufacturing Technology.

It pairs cutting-edge technology with continuous advancement to handle changing conditions, and it sees innovation as central to a sustainable future and to responding to global change.

This role gives quality leadership to assigned product families across the product lifecycle. You work with Product Management, R&D, Operations, Service and Purchasing to monitor product and process performance, turn customer and regulatory requirements into quality objectives, and drive risk-based improvements.

You also own escalated product complaints, run investigations and root-cause analyses, assess possible regulatory reporting duties, and make sure complaints are fully resolved and closed on time.

Responsibilities

• Give quality engineering support to manufacturing, purchasing, R&D and product-sustaining work.
• Act as the Quality Assurance representative and subject-matter expert for assigned product families.
• Build and track product and process quality metrics, spot adverse trends and lead the improvements they call for.
• Use statistical methods for product acceptance, process capability, sampling, data analysis and performance evaluation.
• Assess the quality, regulatory and risk-management effects of product and process changes.
• Lead or support complex quality investigations, root-cause analyses, corrective actions and effectiveness evaluations.
• Handle escalated complaints and keep complaint records complete, accurate, traceable and properly maintained.
• Judge how complaints should be classified, whether they may need regulatory reporting, and whether further investigation, risk evaluation or quality action is required.
• Coordinate complaint investigations, returned-product evaluations, regulatory reporting inputs, stakeholder communication and timely closure.
• Help maintain and continuously improve the Quality Management System.
• Lead quality projects and give technical guidance and training to other personnel.
• Support regulatory inspections and internal or external audits, as required.

Requirements

• Bachelor's degree in engineering, science or a related technical discipline.
• At least five years of relevant experience in quality assurance, product development, manufacturing quality or failure analysis within a regulated industry.
• Working knowledge of ISO 13485, FDA Quality Management System Regulation under 21 CFR Part 820, and applicable U.S. and EU medical device requirements.
• Experience with complaint investigations, root-cause analysis, CAPA, risk management and quality-system processes.
• Skilled in statistical methods, including sampling, process capability, confidence intervals, data-distribution assessment and interpreting quality data.
• Proven ability to lead several complex projects and work effectively across functions.
• Strong written and verbal communication skills.
• Able to adapt and make sound decisions as the environment changes.
• Preferred: experience with medical electronic, ophthalmic, optical or similar regulated products.

Conditions

The annual pay range is $115,900 - $144,900.

Pay may be influenced by job location, scope of role, qualifications, education, experience, and complexity, specialization or scarcity of talent.

This position is eligible for a Performance Bonus.

The company provides equal employment opportunity regardless of race, color, religion, sex, age, national origin, disability, veteran status, citizen status, sexual orientation, gender identity, pregnancy or any other legally protected characteristic.

Benefits

• Medical, vision and dental coverage.
• 401(k) matching and a retirement savings plan.
• Employee assistance programs.
• Paid time off, including vacation and sick pay.