Quality Engineering Technician
US-PA-King of Prussia
Job ID: 2024-4454
Type: Regular Full-Time
# of Openings: 1
Category: Quality
US-PA-King of Prussia
Overview
This is an onsite role for 5 days/week related to daily incoming inspection and quality control for orthopedic implant and reusable instruments. Responsible for contributing, supporting, and maintaining the Receiving Inspection processes within the requirements of FDA’s Quality System Regulations (QSR) and ISO 13485. This position is based in King of Prussia, PA location and will solely focus on S.I. joint implants and associated instruments.
Applying knowledge of Inspection and GMP requirements daily, the duties and responsibilities for this position include, but are not limited to, the following:
- The QE Tech Performs inspections for the Receiving Inspection (RI) area(s) following applicable procedures.
- Responsible for the correct handling of the corresponding fixtures and equipments.
- Correct use of quality inspection records following GMP requirements.
- Ensure consistency and quality of records by editing and proofreading all documentation prior to handling it to the documentation center for storage.
- Maintain and archive documents in an organized and retrievable state (manual or electronic) for compliance with procedures, regulations, and standards.
- Safekeeping all quality records for the RI.
- Schedule periodic document reviews to ensure documents are compliant with Nevro requirements and processes as well as external regulations.
- Communicates corrections and improvement opportunities for departmental SOP, WI, Drawings, and forms and updates them as required.
- Responsible for ensuring timely release of components by executing, reviewing, and approving Lot History Records (LHRs) and ERP transactions per internal requirements.
- Responsible for the control of nonconforming material (identification, segregation)
- Interface with cross functional team to ensure internal and external compliance requirements are followed and implemented per requirements.
- Labelling and segregation of components inspected on the receiving inspection area.
- Notify cross functional departments including Operations, Supply Chain and Quality on component dispositions and/or material holds.
- Managing component disposition and queries.
- Apply proactive, systematic problem-solving methodologies in identifying, prioritizing, communication and resolving quality system issues.
- Support with External Audits activities when required and as directed.
- Perform other duties as assigned.
- Support activities related to Kaizen and Audit preparations.
Responsibilities- Quality Technician or advanced studies in relevant technical discipline required; Quality Technician degree is preferred.
- Five (5)+ years of directly related experience, with at least two (2) of those years in a class II or III medical device environment quality inspection, complaints lab inspection or receiving inspection. Experience in orthopedic implants and instruments is highly desired.
- 5+ years in Quality Assurance functions in the Medical Device industry
Qualifications- Knowledgeable with the FDA, ISO Requirements and QSR requirements
- Experience in the medical device industry and with knowledge performing their function within the Food & Drug Administration (FDA), Quality System Regulations (QSRs), International Organization of Standardization (ISO 13485)
- Practical understanding of mechanical tests/inspections and related good documentation practices.
- Strong communication skills, both verbal and written, and the ability to effectively communicate throughout all levels of the organization and present data to Management when needed.
- Strong technical capability, effective interpersonal skills and being able to work independently.
- Knowledge of documentation systems, specifically quality system (procedures, forms, quality records), and manufacturing (Bill of Material, routers, procedures, Device History Records, Device Master Records) documentation, among others
- Experience with electronic documentation systems such as Arena, EtQ, QAD or similar preferred.
- Knowledge of warehouse management is a plus.
- Cross-functional collaboration with Quality, Engineering, Manufacturing/Production, Supply Chain, etc.
- Strong working knowledge of quality inspection processes and audits (internal and external).
- Strong problem-solving, organizational, analytical, and critical thinking skills.
- Ability to multi-task, work under pressure and meet deadlines required.
- Must be organized, detail-oriented and adaptable.
- Proficiency in Microsoft Office, Access, Excel, Project, as well as exposure to technical document source applications is recommended.
- Ability to communicate effectively.
- Experience related to handling orthopedic implants and reusable instruments is highly desired.
Nevro offers equal employment opportunity, regardless of race, color, creed, religion, national origin, marital or family status, sex, sexual orientation, gender expression (including religious dress and grooming practices), gender (including pregnancy, childbirth or medical condition related to pregnancy or childbirth), physical or mental condition, disability, age or other characteristics protected by laws.
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