Job Description

Roles & Responsibilities

• Conduct complaint investigations and testing for UCC and OEM products.
• Create and maintain investigation files in the complaint system (Trackwise).
• Set up, safely operate, and maintain laboratory equipment and instruments.
• Perform product tests and experiments in accordance with GMP and GLP requirements.
• Maintain accurate data, analyze results, and assist in drawing conclusions.
• Provide Quality Engineering technical support to resolve quality issues, including complaint reviews.
• Ensure compliance with Department and Division procedures.
• Present data findings to peers, engineers, and management staff.
• Work safely in a biohazard environment and adhere to all safety procedures.
• Develop and maintain knowledge of UCC policies, ISO, and FDA requirements.

Experience Required

• Minimum 1–3 years of experience in a regulated industry, including co-op or internship experience.
• Prior laboratory experience is desirable.
• Experience with complaint handling systems (e.g., Trackwise) and data analysis preferred.
• Experience in medical devices or regulated manufacturing environments is advantageous.

Skills & Certifications

• Strong laboratory skills and understanding of laboratory instrumentation.
• Proficiency in MS Excel (pivot tables, v-lookups, etc.).
• Good understanding of OSHA requirements, Quality Systems Regulations (QSR), GLP, ISO, AAMI, and FDA guidelines.
• Excellent communication skills (verbal, written, presentation).
• Strong time management and multi-tasking abilities.
• Ability to interpret regulations and procedures and work independently with minimal supervision.
• Sound judgment and decision-making ability with awareness of regulatory and financial implications.

Eligibilities & qualifications

• Technical or Associate degree in a science-related field (Bachelor’s preferred).
• ASQ certification (CQE, CQA, CQM, etc.) is a plus.
• Basic knowledge of medical device regulations and industry standards required.
  

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