Quality Engineer/Sr. Quality Engineer

Quality Engineer/Sr. Quality Engineer

Direct Hire Full-Time Role

Pay Rate: $55 - $70 per hour

Location: Santa Clara, CA - Onsite Role

Job Summary:

The Quality Engineer must 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. The company does not tolerate retaliation in connection with making good faith reports of suspected violations.

Duties and Responsibilities:

• Investigate and review medical device complaints to help identify root causes, solutions, and trends.
• 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.
• 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)
• Perform Quality role for Sustaining Engineering, New Product 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 the internal quality system 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, 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/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 with standards and the internal QMS.
• Assist in the development, maintenance, and reporting of department metrics.
• Develop/update hazard analyses and FMEAs
• Support the management of eQMS systems, including MasterControl.
• 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 Regulatory.
• Support our Quality System
• Other duties as assigned

Requirements and Qualifications:

• Bachelor's degree in engineering or technical science
• 5 years of directly relevant experience with experience in FDA/cGMP or other regulated environment(s)
• Experience in software validation preferred
• ASQ CQE certification preferred
• Knowledge of industry standards (21 CFR Part 820, ISO 13485, ISO 14971, EU MDR, etc.)
• Knowledge and familiarity of 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 provide guidance on industry practices. This includes 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. Ability 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

Desired Skills and Experience

Medical Device Quality Engineering, Quality Systems, FDA cGMP Compliance, FDA 21 CFR Part 820, ISO 13485, ISO 14971, EU MDR 2017/745, Medical Device Complaints Investigation, Root Cause Analysis, CAPA, Non-Conforming Material Reporting, Deviations Management, Change Control, New Product Development, Sustaining Engineering, Design Change, Design Verification and Validation, V&V Testing, Risk Assessment, Hazard Analysis, FMEA, Sterilization Validation, Cleaning Validation, Biocompatibility Testing, Packaging Validation, Shelf Life Testing, Endotoxin Monitoring, Process Validation, Equipment Qualification, Supplier Quality, Supplier Audits, Vendor Evaluation, Incoming Inspection, Sampling Plans, Acceptance Criteria, Inspection Plans, Statistical Quality Control, Process Capability Studies, Quantitative Data Analysis, Quality Control Procedures, Controlled Documents, Internal Audits, External Audits, Regulatory Compliance, eQMS, MasterControl, Design Controls, Production and Process Controls, Management Review, Calibration and Maintenance Record Review, Technical Design Reviews, Process Improvement, Regulatory Affairs Support, Team Collaboration, Written Communication, Verbal Communication, Mentoring

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