Cadence, Inc. ยท 3 weeks ago
Quality Assurance Engineer II
Sturgeon Bay, WI, US
Full-time
Onsite
Senior Level
5+ years expCadence, Inc. is a Contract Medical Device Manufacturing Organization dedicated to producing cutting-edge medical devices. The Quality Engineer II role involves ensuring compliance with quality standards, leading process improvements, and managing supplier quality to ensure the safety and efficacy of medical devices.
Industrial ManufacturingManufacturingMedical DeviceSupply Chain Management
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 overall product quality
Conduct root cause analysis to investigate quality issues and develop corrective actions to prevent recurrence
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
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
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
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
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
Qualification
Required
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 5-10 years 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
Benefits
Relocation package offered.
Company
Cadence, Inc.
Cadence is a contract manufacturer that fabricates razor-sharp custom-made cutting blades for medical device and diagnostics companies.
501-1000 employees
H1B Sponsorship
Cadence, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (1)
Funding
Current Stage
Late StageTotal Funding
unknown2018-04-18Acquired
Leadership Team
Rob Werge
President and CEO
Ken Cleveland
CFO
Company data provided by crunchbase