Overview
Quality Control Analyst II Jobs in Waukesha, WI at Immucor, Inc.
The Quality Control Supervisor is responsible for leading the quality control team to ensure the achievement of quality requirements, performance goals, and continuous improvement objectives. This role will focus on developing process improvements, addressing deficiencies, and ensuring the accuracy and efficiency of quality processes. The Supervisor will collaborate with production teams, manage performance and attendance, oversee inspections, and support metrology and calibration activities. The role also involves problem-solving related to measurement outcomes and process optimization.
Key Responsibilities:
Team Management: Lead and supervise QC Inspector and Metrology personnel, ensuring efficient inspection and release of parts and finished goods. Manage daily performance, attendance, and work direction for the team.
Leadership and Development: Provide leadership in hiring, performance management, coaching, and training. Foster an environment of safety, diversity, open communication, and trust.
Quality Control: Oversee inspections (First Article, in-process, final) using manual and automated systems (CMM, Keyence, Vision System), blueprint reading, SPC entry, and measurement tools. Conduct Gage R&R, GD&T studies, and product/process validations (IQ/OQ/PQ).
Continuous Improvement: Monitor and track departmental metrics. Develop and implement continuous improvement plans, focusing on Lean manufacturing principles and 6S standards.
Calibration and Maintenance: Ensure that analytical and measurement equipment is properly calibrated and maintained. Oversee preventive maintenance and repair of test equipment.
Non-conformance Management: Participate in Material Review Board (MRB) activities to manage material holds, resolve non-conforming materials and corrective actions.
Documentation and Compliance: Maintain traceability of engineering requirements and ISO documents. Prepare and revise SOPs and ensure adherence to ISO 13485 standards and other regulatory requirements.
Training and Support: Conduct training on analytical instrument operation, metrology, and process validation. Assist in product development by recommending measurement needs and techniques.
Perform other tasks as assigned by management.
Knowledge, Skills, and Abilities:
Technical Expertise: Proficient in using measurement devices like CMM, OGP, Keyence, Optical Comparator, and manual tools (micrometers, calipers, height gages). Strong understanding of metrology and the use of metrology tools.
Software Proficiency: Experience with metrology software (PCDIMS, INSPEC) , SPC software (Minitab, Infinity), Microsoft Excel, Access, and Word.
Problem-Solving: Ability to troubleshoot instrument problems, measurement methods, product defects and interpret data and statistics. Experience in Gage R&R, process validation, and handling non-conforming materials.
Regulatory Knowledge: Familiarity with medical device standards (ISO 13485), FDA 21 CFR Part 820, Good Manufacturing Practices (GMP), and Good Documentation Practices (GDP).
Communication Skills: Strong verbal and written communication skills. Ability to create and review SOPs, document traceability, and provide clear direction and feedback.
Statistical Techniques: Basic understanding of statistical analysis, ANSI sampling plans, and measurement uncertainty.
Training and Leadership: Proven ability to coach, train, and develop teams. Strong leadership capabilities in managing diverse teams and fostering a continuous improvement culture.
Education and Experience:
Education: Associate’s degree in a related field with at least 5 years of QA/QC supervisory experience in a manufacturing environment (medical device preferred). A bachelor’s degree is preferred.
Experience: Minimum of 4-5 years of prior supervisory experience in a manufacturing or quality assurance environment. Experience with process validation, SPC, and medical device quality systems is highly desired.
Certifications: Preferred certifications include ASQ – CQI, CQT, lean, and relevant leadership experience.
Physical and Work Environment:
Ability to work in a manufacturing environment, including clean rooms and handling of non-conforming materials.
Ability to lift and carry test equipment or materials as required.
Job Type: Full-time
Pay: $80,000.00 – $100,000.00 per year
Benefits:
401(k) matching
Dental insurance
Health insurance
Life insurance
Paid time off
Vision insurance
Schedule:
Monday to Friday
Weekends as needed
Work Location: In person
Title: Quality Control Analyst II
Company: Immucor, Inc.
Location: Waukesha, WI
