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Staff Quality Systems Engineer

Company: Advanced Clinical
Location: Palo Alto
Posted on: September 21, 2023

Job Description:

We are currently searching for a skilled professional to join a well-known client's team as a Staff Quality Systems Engineer, in Palo Alto, CA. The Staff Quality Systems Engineer role will be responsible for the support and administration of Quality Systems. This onsite position will ensure compliance to policies, procedures, and regulatory requirements. The individual will work independently and collaboratively to design and implement quality system solutions. Your work will have a direct impact on the organization and the larger clinical industry, making this an amazing career opportunity.RESPONSIBILITIES
--- Support company goals and objectives, policies, and procedures
--- Drive CAPA processes, complaint handling processes, and processing of returned material authorizations, including root cause investigation and closure
--- Manage the internal audit process and management review
--- Manage supplier quality assurance (i.e., supplier evaluations, audits, etc.)
--- Conduct regular quality inspections to ensure that process and procedures adhere to company standards and government regulations
--- Act as an administrator of the quality management software
--- Create, revise and review SOPs and maintain compliance to regulations and ISO requirements
--- Support change control processes including document control and training
--- Manage the quality-related aspects of new hire orientation
--- Gather and analyze quality system data and metrics
--- Identify and participate in implementing proactive quality improvements
--- Update and maintain proper Quality System records, reports, and statisticsEXPERIENCE
--- Minimum of 8 years in Quality Assurance/Quality Engineering role from Medical Device or other regulated industry
--- Regulations experience in any: FDA 21 CFR Part 820, ISO 13485, ISO 14971
--- Lead auditor experience preferredEDUCATION
--- Minimum of Bachelor's Degree in an engineering discipline or equivalentTo be a best-fit your strengths must include:
--- Working knowledge of design controls, risk management, process validation, and statistical techniques.
--- Strong written and verbal communication skills and ability to collaborate effectively
--- Proficient in the use of Microsoft Office SuiteAbout Advanced Clinical
Advanced Clinical is a clinical development and strategic resourcing organization committed to providing a better clinical experience across the drug development journey. Our goal is to improve the lives of all those touched by clinical research - approaching each opportunity with foresight, character, resilience, and innovation. Based on decades of experience, we help our clients achieve better outcomes by conducting candid conversations and anticipating potential issues through our customized solutionsRegarding your application
Please know that every completed application is carefully reviewed by the Advanced Clinical recruitment team. We understand the time commitment that is needed to prepare an application, so we respect your effort by thoughtfully reviewing and responding to each application. In return, we ask for your patience as careful review takes time, and we may not be able to respond to every application immediately.Equal Employment Opportunity
It is Advanced Clinical's practice not to discriminate against any employee or applicant because of sex, race, color, age, national origin, religion, gender, gender identity/expression, sexual orientation/sexual preference, pregnancy/maternity, genetic information, marital status, physical/mental disability, medical condition, military/veteran status, or any other basis protected by applicable federal, state, or local law. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter so that we can discuss the appropriate alternatives available.

Keywords: Advanced Clinical, Palo Alto , Staff Quality Systems Engineer, Other , Palo Alto, California

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