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USA - Product Quality Engineer II
25212 Illinois 120 Round Lake, IL 60073 US
Job Description
*depending on experience
JOB SUMMARY: The Product Quality Engineer (PQE) display basic understanding of the Product Engineering and Quality Management System concepts. Utilizes sound statistical and engineering techniques/tools to investigate non-conformances. As Quality Reviewer, performs document reviews to support design and labeling change controls. Ability to handle multiple projects and demonstrate effectiveness in task completion, decision-making, empowerment of others, exception management, training, problem solving and team leadership. A functional understanding of FDA, ISO and Quality systems is also required.
Utilizes DMAIC tools to investigate non-conformances and participates in (CAPA)-related activities, including CAPA ownership as required.
-Utilizes engineering product development/process knowledge to solve straight forward problems (e.g., FMEA, Finite Element Analysis, Process Modeling, Design of Experiments, Molding, SPC)
-Performs standard engineering assignments to support change controls, new product development, and assists cross-functional teams in identification of risks.
-Supports product testing to ensure product conformance to specifications. 5. Understands principles of complaint handling process and supports complaint investigations.
-Conducts complaint trend analysis and analyzes data from various sources (Non-Conformances, Field -Corrective Actions, and Complaints) to drive decisions.
-Facilitates small project teams as needed to accomplish team objectives.
Supports Quality internal and external audits as required.
Display basic understanding of Quality Management System. Display a technical understanding of engineering and product development principles and procedures. Familiarity with Minitab, power BI desired. Display basic understanding of change controls and risk management principles. Experience in working with cross-
functional teams, including technical and non-technical work. Ability to organize and present technical information with minimal assistance.
Degree in Engineering, with a minimum of 3 years experience in a related environment.
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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