Job Description :
Company Overview:
Creating value by bringing together the right people to achieve results is our motto. Our clients and employees say they choose to work with us because of how we work with them - with service that exceeds their expectations and a personal commitment to their success.
Our client, develops minimally disruptive, procedurally-integrated solutions for spine and beyond seeks accomplished Sr. Quality Assurance Engineer.
* Candidate must be authorized to work in USA without requiring sponsorship *
Description:
Perform quality engineering duties associated with new product development: design requirements and validation, design controls, quality planning, risk management, human factors engineering and establishment of appropriate manufacturing process validations and controls.
Duties to be performed in compliance with applicable regulations and standards including FDA Quality System Regulation 21: CFR 820, ISO 13485, and the European Medical Device Directive.
Design Controls/Quality System:
o Participate in new product development projects by providing quality engineering services to assigned projects. Ensure defendable engineering and scientific analyses are employed and design history files comply with company policies and governmental regulations. Key deliverables including, but not limited to product performance analysis on similar products, risk analysis, failure mode and effects analysis, essential requirements checklist, design verification / validation, design transfer to manufacturing, documentation completion tracking, and product release authorization for distribution of product.
o Must be knowledgeable in IEC 60601, IEC 62304 and IEC 62366
o Participate in software architecture and code review.
Review drawings to evaluate quality requirements including correct application of geometric dimensioning and tolerancing, proper use of engineering, process and material specifications, and identification of key characteristics for inspection plans and methods. Recommend revisions to assure design requirements are specified in the appropriate detail and clarity to provide a successful design transfer. Review and approve engineering change requests. Review product verification and validation plans and approve reports.
Understand and apply the manufacturing quality toolset including PFMEA, IQ, OQ, PQ, GR&R/measurement system analysis, control plans, process verification/validation plans, validation protocol development, Cpk, Cp, SPC, hard gaging applications, computer-based inspection methods, operator work instructions, DOE, process data analysis, and DMAIC.
Assist manufacturing sites with the interpretation of quality requirements including verification/validation planning and execution, first production run requirements, and problem resolution. Develop control plans that identify inspection characteristics, gauging techniques, and sampling requirements. Work with manufacturing sites to resolve conflicts and recommends revisions as required.
Conduct investigations to identify root cause of problems and implement effective corrective actions. Participate in internal audits and suppliers’ evaluations. Assist in the creation/revision of quality system documents.
Assist in coaching and mentoring Jr. or new Quality Engineers
Basic Qualifications:
Requires a bachelor degree in an engineering discipline (e.g. BS Software Eng, BS Computer Eng, BSME, BSEE, or BSBME
Strong knowledge of IEC 62304 and experience supporting both software and hardware systems.
Five years'' experience in a regulated medical device environment in Software Quality Engineering implementing CAPA (21 CFR 820, ISO 13485
Proficiency in interpreting C/C++.
Proficient and accurate with word processing (Word), spreadsheets (Excel), charting, flow charting, and graphs. Competency in navigating the Internet.
Strong mathematical skills, including statistics. (Tolerance analysis, significance tests, process capability, sampling plans, GD&T
Preferred:
American Society for Quality Certified Engineer (CQE) highly desirable.
I''d love to talk to you if you think this position is right up your alley.
If you''re looking for rewarding employment and a company that puts its employees first, we''d like to work with you. We''re driven, people driven.
NOTE: Candidates that are offered a position are required to pass pre-employment background and drug screening. Qualified candidates with criminal histories, are considered in a manner that is consistent with local, state and federal laws.