Quality Assurance Specialist

5 days ago

Milpitas, California, United States Johnson Service Group Full time
Job Description

Johnson Service Group is seeking a highly skilled Quality Engineer to join our team in San Jose, CA.

The Quality Engineer will report directly to the Quality Manager and be responsible for developing and implementing internal manufacturing quality processes and procedures. This includes continuous improvement of assemblies, supporting medical product manufacturing in compliance with regulatory requirements, and providing customer support for quality initiatives.

The Quality Engineer will ensure that medical devices and products meet strict quality and safety standards, including those set by the FDA and ISO. The role involves a variety of tasks aligned with the engineer's training, experience, and skills.

Key Responsibilities:
  • Certified IPC610, J-STD 001, and 7721/11 Trainer: Train exempt and non-exempt personnel in both electronics manufacturing and medical device environments.
  • Lead Auditor: Ensure compliance with regulatory and industry standards for ISO 9001, ISO 14001, ISO medical devices, and OHSAS 18001.
  • Mentor Inspectors and Manufacturing Personnel: Develop expertise in both electronic and medical product quality control.
  • Verify Compliance: Ensure finished assemblies and medical products meet drawings and specifications based on customer and regulatory standards.
  • Create and Coordinate First Article Inspection Reports: Decide whether to release the manufacturing line.
  • Evaluate and Establish Quality Plans: Set quality goals for PCB Assembly, Box build, and medical device manufacturing processes.
  • Perform Statistical Analysis: Review and verify quality reports for medical devices as required by regulatory bodies.
  • Conduct Reject Verification and Analysis: Provide feedback to production line engineering for process or product improvement.
  • Serve as Technical Point of Contact: Support the company and customers, particularly for product quality issues related to medical devices.
  • Develop Product-Specific Quality Inspection Plans: Ensure compliance with FDA and ISO 13485 requirements.
  • Use Quality Tools: Plan and improve processes, focusing on general manufacturing and medical product standards.
  • Make Decisions on Production Stops: Ensure quality issues are addressed, especially in medical device production.
  • Coordinate Customer Audits and Special Customer Approvals: Ensure compliance with regulatory requirements.
  • Set Up Product Audits: Ensure electronic assemblies and medical products meet quality standards.
  • Correctly Read and Interpret Drawings and Specifications: Ensure compliance with medical device standards.
  • Conduct Inspections: Use instruments such as CMM, micrometers, and calipers to ensure compliance with medical device standards.
  • Manage Product and Process Root Cause Analysis: Create customer 8D reports to resolve medical product quality issues.
  • Lead and Drive Continuous Improvement Efforts: Improve processes for electronics and medical products.
  • Perform Training: Teach quality standards, procedures, and work instructions, particularly for medical product manufacturing.
  • Coordinate and Manage Internal Rework: Minimize defects and ensure compliance with medical device standards.
  • Perform Duties with Minimum Supervision: Ensure adherence to medical product quality standards and regulatory requirements.
  • Support and Improve Production Processes: Ensure continuous compliance with regulatory standards.
  • Interface and Support Internal Customers: Coordinate efforts to ensure product quality in electronic and medical product manufacturing.
  • Follow Health and Safety Policies: Ensure patient safety in medical device manufacturing.
  • Support the Quality Management System: Ensure conformance to ISO-based registrations and regulatory controls for medical devices.
  • Perform Related Duties: Complete miscellaneous tasks as assigned, particularly in quality control and regulatory compliance for medical product manufacturing.
Qualifications:
  • Minimum of Four Years of Experience: As a Quality Engineer in an EMS environment, with experience in medical product manufacturing and compliance with FDA and ISO 13485.
  • Bachelor's Degree: In a related field or equivalent experience.
  • Proficient with PC-Based Software: Microsoft Office Suite, with advanced knowledge of Word, PowerPoint, and Excel.
  • Experience with Kaizen, Lean Manufacturing Techniques, and Six Sigma: Green belt preferred.
  • Experience with ISO Standards Implementation: ISO 13485 for medical devices, and familiarity with FDA regulations (21 CFR Part 820).
  • Demonstrated Experience: Developing and documenting procedures for medical products and electronic assemblies.
  • Strong Organizational Skills: Attention to detail, and the ability to multitask in a regulated environment.
  • Ability to Use Common Sense: Solve practical problems and interpret instructions in various formats.
  • Familiarity with Precision Measuring Devices: Electronic equipment used in medical product inspections.
  • Strong Communication Skills: Listening, and interpersonal skills, with the ability to relate to individuals from diverse backgrounds.
  • Self-Directed and Dependable: Strong relationship and time management skills, particularly in regulated medical device environments.
  • Availability: Work the necessary hours and shifts to perform assigned responsibilities, including availability for teleconferences with global teams.

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