Quality Assurance Engineer II

Why should you choose Cadence?

• Shape the Future of Healthcare: Join a team dedicated to producing cutting-edge medical devices that advance patient outcomes and revolutionize healthcare delivery worldwide.
• Challenge Yourself: Take on exciting challenges and solve complex problems as you navigate the dynamic regulatory landscape and continuously improve quality practices in a fast-paced manufacturing environment.
• Be a Leader in Quality Excellence: Lead the charge in furthering our reputation for excellence by implementing best-in-class quality systems and driving continuous improvement initiatives across our manufacturing operations.
• Be Part of Something Meaningful: Join a company that is committed to making a positive impact on people's lives, where your contributions as a Quality Engineer play a vital role in ensuring the safety and efficacy of medical devices that save lives every day.

Key Responsibilities

• Quality Management System (QMS):
• 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.
• Process Improvement:
• Support continuous improvement projects to enhance manufacturing processes, reduce defects, and improve overall product quality.
• Conduct root cause analysis to investigate quality issues and develop corrective actions to prevent recurrence.
• Process Validation:
• Lead and prepare protocols and reports for validation work.
• Coordinate validation activities with constant communication with affected departments and personnel.
• Provides oversight and leadership of process validation status and revalidation activities.
• Programming CMM Software:
• Develop and write CMM programs using specialized software based on engineering drawings and specifications.
• Create measurement routines to inspect specific features and dimensions of parts.
• Supplier Quality Management:
• Qualify and manage suppliers, ensuring that raw materials and components meet required specifications for medical device manufacturing.
• Perform supplier audits and work with vendors to resolve quality-related issues.
• Documentation and Compliance:
• Prepare and review technical documentation, including protocols, validation plans, work instructions, and Standard Operating Procedures (SOPs).
• Ensure all documentation is maintained in compliance with applicable regulations and that records are accurate and traceable.
• Track and report on key quality metrics, including defect rates and audit findings.
• Training and Mentorship:
• Provide quality training to staff on cleanroom operations, regulatory compliance, and quality standards.
• Support cross-functional teams in addressing quality concerns and implementing best practices for continuous improvement.

Qualifications

• Must have extensive experience with reading mechanical drawings and utilization of precision measuring instruments.
• Must be well versed in Geometric Dimensioning and Tolerancing.
• Bachelor's degree in Engineering or related field or equivalent experience.
• Minimum of 1 year of experience in quality engineering or related roles within the medical device industry.
• Strong knowledge of FDA regulations (21 CFR Part 820), ISO 13485, and other relevant quality standards.
• Experience with risk management methodologies (e.g., FMEA, FMECA) and statistical analysis techniques.
• Proficiency in quality tools and methodologies, such as root cause analysis, CAPA, process validation, 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. Relocation package offered.