Quality Assurance Engineer II
About The Position
Cadence is seeking a Quality Engineer II for its contract medical device manufacturing organization at its Sturgeon Bay, Wisconsin site. The role ensures that products are manufactured and delivered in accordance with rigorous quality standards and applicable regulations, including ISO 13485 and FDA requirements. The engineer works with manufacturing, engineering, regulatory, supplier, and other cross-functional teams to support compliant and reliable manufacturing processes and products. The position supports new product introduction and process validation; analyzes quality data; prepares validation and quality documentation; leads root cause analysis and corrective actions; and supports continuous improvement. It also contributes to maintaining the Quality Management System and accurate, traceable records, developing inspection and measurement routines, creating work instructions, and training staff on quality standards and measurement techniques. The role is primarily onsite, and a relocation package is offered.
Requirements
- Extensive experience reading mechanical drawings and using precision measuring instruments.
- Well versed in Geometric Dimensioning and Tolerancing (GD&T).
- Bachelor's degree in Engineering or a related field, or equivalent experience.
- At least 1 year of experience in quality engineering or related roles within the medical device industry.
- Strong knowledge of FDA regulations, including 21 CFR Part 820, ISO 13485, and other relevant quality standards.
- Experience with risk management methodologies such as FMEA or FMECA and statistical analysis techniques.
- Proficiency in quality tools and methodologies, including root cause analysis, CAPA, process validation, and statistical analysis.
- Excellent communication, problem-solving, and interpersonal skills.
- Ability to work effectively in a fast-paced, team-oriented environment.
- Willingness and ability to work primarily onsite.
Responsibilities
- Ensure compliance with ISO 13485, FDA 21 CFR Part 820, and other relevant standards.
- Coordinate and support internal and external audits, including supplier audits and regulatory inspections.
- Lead Corrective and Preventive Actions (CAPA) to address non-conformances and ensure timely closure of quality events.
- Support continuous improvement projects to enhance manufacturing processes, reduce defects, and improve product quality.
- Conduct root cause analysis of quality issues and develop corrective actions to prevent recurrence.
- Prepare protocols and reports for validation work and coordinate validation activities with affected departments and personnel.
- Provide oversight and leadership for process validation status and revalidation activities.
- Develop CMM programs using specialized software based on engineering drawings and specifications.
- Create measurement routines to inspect specific part features and dimensions.
- Qualify and manage suppliers to ensure raw materials and components meet medical device manufacturing specifications.
- Perform supplier audits and work with vendors to resolve quality-related issues.
- Prepare and review technical documentation, including protocols, validation plans, work instructions, and SOPs.
- Maintain documentation and records in compliance with applicable regulations, ensuring accuracy and traceability.
- Track and report quality metrics, including defect rates and audit findings.
- Train staff on cleanroom operations, regulatory compliance, and quality standards.
- Support cross-functional teams in resolving quality concerns and implementing continuous-improvement practices.
Benefits
- Relocation package offered
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
