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Mfg/Ops Quality Engineer 1

Hayward, CA 94545

Posted: 08/20/2024 Employment Type: Contract Job Category: QA/Automation Job Number: 613965 Is job remote?: No Country: United States

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 “Zero Defect” 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

Education:

Bachelor’s degree, ideally in an engineering discipline

The staffing 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 and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.

Planet Pharma and The Planet Group of Companies are equal opportunity employers. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.

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About Hayward, CA

Discover exciting job opportunities in and around Hayward, California! Located in the East Bay area of the San Francisco Bay region, this bustling city offers the perfect blend of career growth and quality of life. With its close proximity to Silicon Valley, Hayward provides a gateway to endless possibilities in tech and innovation. Enjoy the stunning views of the San Francisco Bay, explore the Hayward Japanese Gardens, or catch a show at the historic Chabot Theater. Indulge in diverse cuisines from the local eateries or take a stroll through the Hayward Area Historical Society. Join us in Hayward for a thriving job market and a vibrant community waiting to welcome you with open arms. Explore our job listings today and embark on an exciting career journey in this charming city!

Although this hasn't been an issue at Planet Pharma, the staffing 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 and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.