Sanmina Corporation (Nasdaq: SANM) is a leading integrated manufacturing solutions provider serving the fastest-growing segments of the global Electronics Manufacturing Services (EMS) market. Recognized as a technology leader, Sanmina Corporation provides end-to-end manufacturing solutions, delivering superior quality and support to Original Equipment Manufacturers (OEMs) primarily in the communications networks, defense and aerospace, industrial and semiconductor systems, medical, multimedia, computing and storage, automotive and clean technology sectors. Sanmina Corporation has facilities strategically located in key regions throughout the world.

Quality Medical Supervisor

Job Purpose:

To supervise the Quality Team in our Medical Device Manufacturing Group in Carrollton, TX.

Job Duties/Responsibilities:

• Lead Quality Assurance in support of manufacturing activities in accordance with the requirements of USFDA CFR 820 and ISO13485
• Manage validation activities as established by USFDA CRF 820, ISO 13485
• Support engineering efforts by developing, implementing, and maintaining quality requirements and standards throughout the design transfer and manufacturing of products
• Drive product risk management activities and ensure quality and completeness of project design history files, validation packages, and change orders
• Provide ongoing quality engineering support throughout the product life cycle. Provide support to development, engineering and manufacturing functions for validation planning and transfer activities. Assist teams in determining validation needs strategies and requirements. Ensure product development and validation programs meet requirements of FDA and ISO when applicable
• Lead in the implementation of assurances, process controls, and CAPA systems designed to meet or exceed internal and external requirements
• Manages Quality Notifications (QN) for non-conforming product and deviations. Monitors Quality Notification progress and works with cross-functional team to complete QN per requirements.
• Maintain a knowledge base of lessons learned to enable continuous improvement
• Oversee QC Inspectors and ensure adherence to procedures
• Provide management with status updates on assigned responsibilities and goals and escalate issues in a timely fashion
• Writes detailed Risk Assessments, updates Process Hazard Analysis, and present analysis to the Risk Management Board
• Trend, analyze, and report on quality data in order to improve product and process; develop recommendations based on data analysis

Education & Experience:

• High School Diploma or equivalent
• 6+ years quality engineering experience in a medical manufacturing environment for a company in a regulated industry required - medical device manufacturing preferred
• ASQ CQE certification is a plus
• Six Sigma Certified Green or Black Belt is a plus
• Working knowledge of FDA QSR (21 CFR Part 820), ISO 13485 and ability to understand other medical device regulations and standards
• Strong communication, presentation, facilitation, and project management skills
• Experience working in cross-functional teams and driving projects to completion
• High sense of urgency and commitment to execution
• Applies continuous improvement principles in the development of the quality system
• Driven, energetic, self-assured professional with high personal integrity
• Knowledge of analytical techniques and statistical analysis
• Ability to develop effective, positive interpersonal relationship

Skill Set:

• Medical Device Manufacturing
• Supply Chain
• Manufacturing Management & Leadership
• Supply Planning
• MVP and Validation
• Process Improvements
• CAPA
• Quality and Regulatory Knowledge

Physical Demands

Work is performed in an office and a manufacturing environment. Required to stand, walk, sit, stoop, bend; talk and hear in person; use hands to finger, handle or feel objects or controls; reach with hands and arms; substantial movements (motions) of the wrists, hands, and/or fingers; repetitive motion. Specific vision abilities required by this job include close vision, distance vision, depth perception, color vision and the ability to adjust focus. Occasionally may need to exert up to 30 pounds of force to lift, carry, push and pull or otherwise move objects.

Sanmina is an Equal Opportunity Employer - M/F/Veteran/Disability/Sexual Orientation/Gender Identity