Job Description

Product Complaint Analyst needed for a contract opportunity with Yoh Scientific’s client in San Diego, CA. This position is in the Quality Assurance department of a major life science technology company, and requires 2+ years of Quality/Regulatory Affairs experience in medical device or in-vitro diagnostics. Key Responsibilities: • Work closely with investigation teams to identify, assess and track potential adverse events and/or field actions and escalate to Regulatory in a timely manner • Monitor new and revised regulatory requirements in the area of Regulatory Compliance and translate information into area processes • Participate and assist during audits and/or inspections as needed • Actively participate on Quality teams and cross-functional project teams as needed • Facilitate the evaluation of complaints, including assessment, investigation, containment, review, approval and determination of on-going needs • Ensure adequacy of complaint records (e.g. investigations, CAPA, NCs) Identifies, collects, trends, analyzes, and summarizes product quality data to identify product quality issues • Identifies product and process improvements to reduce complaints and cost of poor quality • Promotes global awareness and provides training to policy and procedures • Provides support in the execution of field actions • Contributes to the establishment and maintenance of product risk management • Provides recommendations for business process improvements as they are identified during the analysis, tracking, and trending of quality review inputs • Provides management with status updates on assigned responsibilities and goals and escalates issues in a timely fashion Qualifications: • 2+ years recent experience in Quality/Regulatory Affairs in a in vitro diagnostics device or medical device preferred • Knowledge of U.S. FDA regulations of medical device/IVD adverse event and field action assessment, health hazard evaluation, product risk safety analyses, MDR/recall reporting, IVD/Medical Device labeling requirements and 21 CFR 820 and process requirements • Knowledge of Vigilance reporting to OUS regulatory agencies desired Opportunity is Calling, Apply Now! Recruiter: Mary Nestojko, Mary.Nestojko@yoh.com What’s In It For You? We welcome you to be a part of one of the largest global staffing companies to meet your career aspirations. Yoh’s network of client companies has been employing professionals like you for over 65 years in the U.S., UK and Canada. Join Yoh’s extensive talent community that will provide you with access to Yoh’s vast network of opportunities and gain access to this exclusive opportunity available to you. • 401K Retirement Saving Plan • Direct Deposit & weekly ePayroll • Employee Discount Programs • Referral Bonus Programs Yoh makes finding and applying for jobs simple. Partner with Yoh to find the right opportunities across multiple industries in the US and UK. Find out more here! Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. Visit HTTPS://WWW.YOH.COM/APPLICANTS-WITH-DISABILITIES to contact us if you are an individual with a disability and require accommodation in the application process.