Associate Quality Engineer

Associate Quality Engineer

Direct Hire Full-Time Role

Salary Range: $93,600 - $104,000 per year

Location: Santa Clara, CA - Onsite Role

Duties and Responsibilities:

• Provide Quality Department support for our products, ensuring that our actions result in meeting our customer needs while maintaining compliance with federal law and applicable standards.
• Perform all duties in compliance with all applicable worldwide regulatory requirements as included in the scope of the company Quality Manual.
• Investigate and review medical device complaints in conjunction with Regulatory Affairs.
• Act and conduct company business in an honest, ethical, and lawful manner, consistent with the company's Code of Conduct, other company policies, and the AdvaMed Code of Conduct and/or any other applicable industry code(s) of conduct.
• Investigate and review medical device complaints to help identify root causes, solutions, and trends.
• Perform risk assessments.
• Write protocols and reports for activities such as sterilization validation, cleaning validation, biocompatibility testing, and packaging validation for New Product Development.
• Support New Product Development activities, such as assessment and characterization of design, process, and use risks, design Verification and Validation (V&V) testing.
• Develop requirements for sterilization and monitoring of sterilization and endotoxins for new products.
• Support and write reports for real-time shelf life testing as part of packaging validation testing of new products.
• Write system requirement specifications, risk analyses, software validation protocols and reports, and traceability matrices.
• Advise the manager of factors that may affect the quality of the product, initiate reports for deviations and non-conforming materials, and provide guidance/options and ideas for corrective actions and preventive actions (CAPA) Development, Design Change (DC) projects and Non-Standard Products (NSPs).
• Assist the Quality team daily to accomplish efficient and effective review and approval of records as assigned, including, but not limited to, calibration and maintenance work, procedures, validation protocols, validation reports, deviations, and change controls.
• Monitor and ensure compliance with internal quality systems and external industry regulations.
• Perform activities pertaining to supplier audits, i.e., audit plans, audit execution, and audit reports.
• Handle supplier changes and work with Engineering and other departments as appropriate to implement changes in standard operating procedures.
• Develop and maintain inspection and Quality control procedures.
• Provide direction in developing supplier and incoming inspection plans, sampling plans, inspection, and acceptance criteria for new products.
• Provide direction for supplier controls for new products, DCs, and NSPs, including performing vendor audits and evaluations.
• Help handle and maintain ASL for new products, DCs, and NSPs, and support Sustaining suppliers as required.
• Support CAPAs, NMRs, Deviations, and Extension/Scope Changes for new, sustaining products, DCs, and NSPs.
• Assist in developing and improving departmental procedures and other controlled documents.
• Evaluate the adequacy of specifications for new or modified process designs.
• Participate in process and technical design reviews and design reviews that are part of the five-phase device development.
• Develop, review, and approve process and equipment validations and qualifications for Sustaining, New Product Development, and DC applications.
• Perform new product process evaluations, including process capability studies, to identify areas for improvement and to reduce variability and lower total quality costs.
• Assist Regulatory Affairs and Engineering personnel in new product/process design to ensure effective control procedures are established.
• Support internal/external audits to assess compliance to standards and to the internal QMS.
• Assist in the development, maintenance, and reporting of department metrics.
• Develop and update hazard analyses and FMEAs.
• Support the management of eQMS systems.
• In the event of potential non-compliance with applicable standards or regulations (e.g., FDA QSRs, ISO 13485, or ISO 14971), the employee has the authority to hold any product or Quality documentation from shipment or further processing. The employee has the responsibility and authority to report any instances to Quality management and/or Regulations.
• Support the company's Quality System.

Requirements and Qualifications:

• Bachelor's degree in engineering or technical science
• 3+ years of directly relevant experience in FDA/cGMP or other regulated environment(s)
• Experience in software validation is preferred.
• ASQ CQE certification is preferred.
• Knowledge of industry standards (FDA QSRs, ISO, MEDDEV, etc.)
• Knowledge and familiarity with applicable regulations/standards (e.g., ISO 13485, FDA 21 CFR 820, EU MDR 2017/745, ISO 14971) as required to perform the job function
• Experienced in QMS requirements and able to guide industry practices, including design control, production and process controls, supplier controls, corrective and preventive action, management review, and non-conforming material controls
• Demonstrated ability to drive and deliver innovative, effective, and timely solutions. Able to mentor others in best practices and industry standards.
• Demonstrated ability to acquire and analyze data using appropriate standard quantitative methods across a spectrum of business environments to facilitate process analysis and improvements
• Strong knowledge of statistical quality tools with process capability and statistical quality control methodologies; demonstrated ability to determine sampling plans based on confidence and reliability
• Experienced with managing and developing suppliers
• Excellent verbal and written communication skills
• Must be a team player

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