We are looking for a dedicated
Quality Engineer II to ensure the highest standards of quality and compliance throughout our manufacturing processes at our
Sturgeon Bay, WI site. As a
Quality Engineer II for a Contract Medical Device Manufacturing Organization, you will be responsible for ensuring that all products are manufactured and delivered according to the strictest quality standards. You will work closely with manufacturing, engineering, and regulatory teams to ensure compliance with ISO 13485, FDA, and other applicable medical device regulations. Your role supports new product introduction by developing and implementing inspection, testing, and validation methods to ensure reliable manufacturing processes and products. This role analyzes data, generates validation and quality documentation, drives root cause analysis and continuous improvement, maintains the Quality Management System and Device History Records, creates work instructions, and trains staff on proper measurement techniques to ensure product conformity.
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 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. Relocation package offered.
