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Engr II
17011 Red Hill Avenue Irvine, CA 92614 US
Job Description
Target PR Range: 40-50/hr
*Depending on experience
Job Description:
Perform Post Market customer complaints investigations, providing detailed analysis of the process and the data; determine root causes of the nonconformities in order to establish corrective and preventive actions. Execute complaint investigations multifunctional approach and issues addressed in a systematic, methodical manner. Oversight of all complaints that require investigation through the different phases. Ensure on time completion of complaints. Work closely with complaint investigation owners to resolve issues and ensure those that have passed their due dates are addressed. Ensure complaint investigations are adequate and comply with applicable procedures.
Applies knowledge of quality engineering principles and methods to ensure compliance with regulatory requirements and systems/procedures to optimize product development, internal and external device manufacturing, and device distribution. Please refer to the job description for additional details.
Key Responsibilities:
- Investigate moderately complex product quality and compliance issues (e.g., CAPA, non-conformances, audit observations) for all production processes prior to final product release based on engineering principles; analyze results, make recommendations and develop reports.
- Develop, update, and maintain technical content of risk management files
- Develop training and documentation materials for production (e.g., work instructions) to enable the seamless knowledge transfer of project and manufacturing processes
- Assign support tasks; gives instruction to technicians on conducting tests; trains technicians and provides feedback; and may coordinate technician work.
- Other incidental duties assigned by Leadership
Additional Skills:
- Proficient at MS Suite, especially Excel and Power Point
- Experience with Power BI
- Understanding of data trending and analytics, data pulls/refresh data sources
- Post market surveillance experience
-
General background/understanding of Post Market Analysis:
Complaints FCA PRA CAPA -
Understanding of regulations, a plus; EUMDR, FDA, ISO standards
- Medical device experience
- Excellent writing skills
- Ignite preferred
- ETQ (Reliance) experience preferred
Education and Experience: Bachelor's Degree in in Engineering or Scientific field including either industry or industry/education, minimum of 2 years' experience Required
Or
Master's Degree or equivalent in in Engineering or Scientific field including either industry or industry/education Required or internship, senior projects, or thesis Required
Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
Fraud Alert: Candidate safety is a top priority at Planet Pharma. The industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it’s from an official Planet Pharma domain (@planet-pharma.com, @planet-pharma.co.uk, and @ppgadvisorypartners.com) and not a domain with an alternative extension like .net, .org or .jobs.
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