Principal Quality Engineer

3 weeks ago


San Diego, United States Actalent Full time

Job Title: Principal Quality EngineerJob DescriptionBe a key contributor in the new product development process, which will include design assurance, risk analysis, risk management, product redesign and enhancements, supplier management, as well as manufacturing and technology transfer. Devise, implement, and conduct methods and procedures to validate product software and/or hardware systems utilized to support. Act as a Subject Matter Expert (SME) for instrumentation and manufacturing support as it relates to Quality, including assessing the impact of hardware and software changes submitted by contract manufacturers, and third parties. Perform statistical analysis of data from manufacturing and quality testing/inspection to identify trends and opportunities for improvement. Design, compile, and analyze trends in product/process performance from new product development through service, coordinating any required root cause analysis and corrective actions. Manage/lead technical, external audits (critical suppliers, Third Party Manufacturers), as required. Lead compliance investigations and trending, document findings, recommend and implement corrective action and appropriate follow-up, as necessary. Support risk management activities and recommend an appropriate course of action via CAPA systems. Collaborate with internal functions, affiliates and third parties to complete post-market surveillance for instrumentation systems.Hard SkillsDesign controlDesign verificationISO 1348521CFR Part 820 Skills / Pre-requisites: •Expert knowledge and experience of the quality assurance system including Quality System Regulation 21CFR part 820, ISO 13485, CMDR, JPAL •Effective written and oral communication, interpersonal skills, facilitation and influencing skills with an ability to effectively work with internal and external stakeholders •Experience managing in a multi-site, multi-national organization - able to appreciate the geographical and cultural differences •Proficiency with MS Office and software programs for generating reports, presentations, and statistics (Minitab) •Ability to lead problem-solving efforts (via 8D, 5 Why, Fish Bone, etc.) to identify and resolve product or process challenges, as well as compliance issues •Job TypeContractWork SiteThis is a fully on-site position in San Diego, California.Work EnvironmentWorking cross-functionally with all technical departments. Not an individual contributor but helping coordinate work from different departments for 510k.About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. Diversity, Equity & Inclusion At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through: Hiring diverse talent Maintaining an inclusive environment through persistent self-reflection Building a culture of care, engagement, and recognition with clear outcomes Ensuring growth opportunities for our people The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.



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