Quality Engineer- Medical - Johnson Service Group

Johnson Service Group is looking for a Quality Engineer for one of our clients in San Jose, CA. The Quality Engineer reports directly to the Quality Manager and is 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 role involves ensuring that medical devices and products meet strict quality and safety standards, including those set by the FDA and ISO 13485. The Quality Engineer may perform a variety of tasks aligned with their training, experience, and skills.

Essential Functions and Responsibilities:

• Certified IPC610, J-STD 001, and 7721/11 trainer, with the ability to train exempt and non-exempt personnel in both electronics manufacturing and medical device environments.
• Lead auditor for ISO 9001, ISO 14001, ISO 13485 (medical devices), and OHSAS 18001, ensuring compliance with regulatory and industry standards.
• Mentor inspectors, assemblers, and manufacturing personnel to develop expertise in both electronic and medical product quality control.
• Verify compliance of finished assemblies and medical products with drawings and specifications based on customer and regulatory standards (including FDA and ISO 13485).
• Create and coordinate First Article Inspection (FAI) reports for both electronic and medical products, deciding whether to release the manufacturing line.
• Evaluate and establish quality plans and set quality goals for both PCB Assembly, Box build, and medical device manufacturing processes.
• Perform statistical analysis of processes through trend charts, control charts, DOE, PFMEA, and other tools; review and verify quality reports for medical devices as required by regulatory bodies.
• Conduct reject verification and analysis to provide feedback to production line engineering for process or product improvement, with a focus on ensuring compliance with medical device standards.
• Serve as the technical point of contact between the company and customers, particularly for product quality issues related to medical devices.
• Develop product-specific quality inspection plans for medical products and electronic assemblies, ensuring compliance with FDA and ISO 13485 requirements.
• Use quality tools for planning and improvement, focusing on both general manufacturing and medical product standards.
• Make decisions on production stops at each step if quality issues arise, especially in the context of medical device production, where safety and regulatory compliance are critical.
• Coordinate customer audits and special customer approvals for deviations, especially in relation to medical products that must meet strict regulatory requirements.
• Set up product audits as needed, ensuring both electronic assemblies and medical products meet the required quality standards.
• Correctly read and interpret detailed assembly-level drawings and customer specifications, including those for medical products subject to FDA regulations.
• Conduct inspections using a variety of instruments (e.g., CMM, micrometers, calipers), ensuring compliance with medical device standards and specifications.
• Manage product and process root cause analysis with the engineering team and create customer 8D reports, ensuring medical product quality issues are resolved according to regulatory standards.
• Lead and drive continuous improvement efforts (CIP) for both electronics and medical products.
• Perform training on quality standards, procedures, and work instructions, particularly for medical product manufacturing in compliance with ISO 13485.
• Coordinate and manage internal rework, with a focus on minimizing defects and ensuring compliance with medical device standards.
• Perform duties with minimum supervision, ensuring adherence to medical product quality standards and regulatory requirements.
• Support and improve production processes, particularly in relation to medical products, ensuring continuous compliance with regulatory standards.
• Interface and support internal customers (production, quality, engineering), coordinating efforts to ensure product quality in both electronic and medical product manufacturing.
• Follow all health and safety policies at all times, particularly in relation to medical device manufacturing, where patient safety is a priority.
• Support the Quality Management System, ensuring conformance to ISO-based registrations and regulatory controls for medical devices.
• Perform related duties and miscellaneous tasks as assigned, particularly in relation to quality control and regulatory compliance in medical product manufacturing.

Qualifications Required/Job Specifications:

• Minimum of four (4) 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, including 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, particularly 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 to solve practical problems and interpret instructions in various formats.
• Familiarity with precision measuring devices and electronic equipment used in medical product inspections.
• Strong communication, listening, and interpersonal skills, with the ability to relate to individuals from diverse backgrounds and gain support across all levels of the organization.
• Self-directed, dependable, and motivated, with strong relationship and time management skills, particularly in regulated medical device environments.
• Available to work the necessary hours and shifts to perform assigned responsibilities, including availability for teleconferences with global teams.

Salary starting at $90k DOE
#D800
** Johnson Service Group (JSG) is an Equal Opportunity Employer. JSG provides equal employment opportunities to all applicants and employees without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, marital status, protected veteran status, or any other characteristic protected by law.