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Mfg/Ops Quality Engineer 1
25861 Industrial Boulevard Hayward, CA 94545 US
Job Description
Target Pay Rate: 34.25-42.75/hr **salary will be commensurate with experience
Responsibilities:
Provide key support for management of nonconforming material NC RMA and deviations to ensure timely and efficient resolution of manufacturing interruptions and/or component quality issues Develop subject matter expertise in SAP workflows for RMA and NCM handling Executes usage decisions for RMA in line with QMS requirements Verify accuracy and compliance of NC and deviation records Plan and execute all aspects of material containment including physical and system transactions and management of holds Collaborate as part of cross-functional team to implement process improvements and/or resolve material or process issues Support global project implementations e.g. with system testing local stakeholder communications etc Ensures adequacy of nonconformance deviation and CAPA records investigations and corrective actions Become familiar with the applicable technology to facilitate participation in technical discussions and risk-based decision making Assist with material inspections as needed Maintain company documentation related to assigned functions e.g. work instructions forms Promote aZero Defecta mentality throughout the manufacturing process Provide logistics support to external audits Other activities as assigned
Listed responsibilities are an essential but not exhaustive list of the usual duties associated with the position. Changes to individual responsibilities may occur due to business needs.
Requirements:
0-3 years experience in Quality Assurance supporting manufacturing in a regulated environment equivalent manufacturing experience with demonstrated Quality mindset may substitute Experience applying quality regulations and standards e.g. 21CFR 820 ISO 13485 to actual situations Practical experience with design controls risk management validation and/or change control desired Experience with CAPA and failure investigation tools and techniques desired Adaptable to fast-paced dynamic work environment with shifting demands Must have strong verbal and written communication skills work well with diverse groups of people and be able to function independently of direct supervision
All listed requirements are deemed as essential functions to this position however business conditions may require reasonable accommodations for additional tasks and responsibilities.
Education:
Bachelors degree ideally in an engineering discipline
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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