Company Description
Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. Eurofins PSS gives our clients an insourcing solution for all of their analytical testing needs. Are you looking for the opportunity to use your skills in order to impact a team in a fast paced environment towards our ultimate goal of testing for a better life? We can provide you meaningful work in a highly supportive and collaborative environment where we invest in you because our people are our chemistry!
Job Description
Monitor, triage and assign complaints timely and appropriately.
Understand the devices to support investigations as defined in associated complaint procedures.
Perform and/or lead detailed complaint investigations.
Perform examinations on returned complaint samples as applicable.
Ensure timely completion of complaint investigations.
Supports ad hoc complaint requests when necessary.
Utilize Failure Modes and Effects Analysis (FMEA), as applicable.
Utilize non-routine software tools or business systems to complete complaint investigations.
Ensure compliance with Medical Device Reporting (MDR) and other regulatory reporting requirements.
Qualifications
Basic Minimum Qualifications: Associate's degree in engineering, medical or life sciences
Strong written, oral and interpersonal skills
Strong technical writing skills
Strong attention to detail, time management, teamwork, and ability to multi-task
Ability to work in a dynamic and fast-paced environment
Experience Desired:
Previous experience with deviation and/or complaint investigation processes
Proficiency in Mocrosoft Office Suite, SAP, Trackwise, Stature, Darwin and Veeva Vault programs
Experience in Manufacturing QC, QA, Technical Services or Regulatory
Knowledge of cGMP's
Knowledge of global medical devices and combination product regulations (e.g., 21CFR820, 21CFR Part 4, Part 11, ISO 11608, Canadian MDR, EU Medical Devices Directive/Regulation, JPAl, TGA, ANVISA)
Additional Information
Position is full-time, Monday - Friday. Candidates currently living within a commutable distance of Indianapolis , IN are encouraged to apply. Excellent full-time benefits including comprehensive medical coverage, dental, and vision options. Excellent full-time benefits including comprehensive medical coverage, dental, and vision options
Life and disability insurance
401(k) with company match
Paid vacation and holidays
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Eurofins is aM/F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer.
PandoLogic. Keywords: Quality Control / Quality Assurance Specialist, Location: INDIANAPOLIS, IN - 46259 , PL: ********
