Quality Engineer

Join a startup team that is advancing their life saving product to market as a Quality Engineer! This team is rapidly growing and is aiming to save a countless amount of lives! The Quality Engineer role will focus on working with external suppliers to investigate and resolve non-conformance issues. This role will require some domestic travel. This is a direct hire opportunity. Candidates should have at least 5+ years of manufacturing engineering experience in medical devices. Some candidates may be eligible for relocation assistance. location: HUNTINGTON BEACH, California job type: Permanent salary: $90,000 - 98,000 per year work hours: 8am to 4pm education: Bachelors Responsibilities Lead Quality Investigations: Take the lead on supplier Nonconformance Reports (NCRs), from identifying the initial issue to determining the root cause and verifying corrective actions. Manage Supplier Relationships: Collaborate with suppliers to ensure timely resolution of quality issues and effective implementation of corrective and preventive actions (CAPA). Ensure Regulatory Compliance: Develop, author, and maintain comprehensive NCR documentation in compliance with ISO 13485, 21 CFR 820, and other applicable regulations. Conduct Audits: Perform on-site supplier audits and process inspections. You'll also provide technical guidance to help suppliers address non-conformances and support internal/external audits. Drive Continuous Improvement: Contribute to supplier evaluations and support follow-up on quality-related issues to enhance overall supplier performance. Collaborate Across Teams: Partner with R&D, Manufacturing, and Regulatory Affairs to ensure that all supplier-provided materials meet design and manufacturing requirements. Support Quality System Activities: Assist with the receiving and inspection of materials, manage quality records, and contribute to process validation and facility controls. Qualifications 5+ years in medical device quality or manufacturing with 2+ years of at least class 2 experience Knowledge of ISO 13485, 21 CFR 820, and ISO 14971 Benefits Medical, Dental, 401K, Profit Sharing and PTO/Holiday Pay Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

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