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Quality Systems Engineer

Waltham, Massachusetts | Concord, California

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Job ID JR0000205

Quality Systems Engineer, Fresenius USA, Inc., a Fresenius Medical Care N.A. company Concord, CA

Purpose and Scope:

Responsible for representing Fresenius Medical Care’s Concord, California facility’s quality initiatives and ensuring that regulated computer systems are developed, validated and maintained in compliance with corporate software validation lifecycle policies and procedures.

Principal Duties and Responsibilities:

  • Developing, reviewing and improving the facility’s Quality Plan and manufacturing processes. Applies company policies and procedures to represent the Quality Systems Department on software development teams.
  • Reviewing processing procedures in new and existing programs to assure enhanced quality and productivity while remaining in compliance with FDA/cGMP/QSR. Assisting the Quality Systems and Production operations with compliance to QSR requirements.
  • Partnering with business teams and IT to ensure that computerized quality systems are compliant with FMCNA procedures, FDA Quality System Regulations, 21 CFR Part 11, and GAMP5.
  • Creating and/or assisting business owners/teams and IT in the definition and creation of business requirements, functional specifications, and system specifications as necessary.
  • Utilizing current acceptable industry/FDA requirements to justify, write, and implement software validations and GMP procedures. Drafting, reviewing, and assisting in the implementation of validation protocols, final validation reports, Quality System procedures, performance qualifications and Change Control. Maintaining validation records and systems to keep ongoing processes or software validations current and applicable to the process.
  • Creating and/or overseeing the creation of validation deliverables including but not limited to validation assessments, validation plans, test plans, test protocols, test reports, validation summary reports, and trace matrices, as needed to support local and enterprise system implementation in a regulated (FDA) environment. Leads the review and approval of validation deliverables.
  • Executing test protocols as necessary. Conducting independent reviews of test executions.
  • Supporting internal and external audits/inspections by presenting and defending system validation projects and documentation during audits and FDA inspections as Subject Matter Expert.
  • Conducting risk analysis (Fault Tree, FMEA, FMECA, HASAP or equivalent accepted methods) as part of design control for new and existing product lines to identify potential hazards associated with the device design under both normal and fault conditions.

Education Experience and Required Skills:

This position requires a Master’s degree (or equivalent foreign degree) in Electrical Engineering, Industrial Engineering, Manufacturing Engineering, or a closely related field and 3 years of experience performing software validation and verification in support of medical device systems. Alternatively, will accept a Bachelor’s degree (or equivalent degree) in Electrical Engineering, Industrial Engineering, Manufacturing Engineering or a closely related field and 5 years of experience performing software validation and verification in support of medical device systems.

Experience, which may have been gained concurrently with the primary experience requirement above, must include 3 years of experience: (i) performing validation in support of medical device manufacturing (in accordance with IQ, OQ and PQ standards); (ii) utilizing current industry and  FDA regulatory requirements (GLP/CMP/QSR) to justify, write, and implement processes or software validations and GMP procedures; (iii) performing reviews and/or assists on all SDLC documents, protocols and SOP's to ensure they meet GMP and FDA regulations; (iv) developing and reviewing user requirement specifications URS, functional requirements specification FRS and requirement traceability matrix RTM documents.

This position requires 15% domestic travel.

EO/AA Employer: Minorities/Females/Veterans/Disability/Sexual Orientation/Gender Identity

Fresenius Medical Care North America maintains a drug-free workplace in accordance with applicable federal and state laws.

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