The Senior Quality Engineer (QE) will provide support for product/process quality activities within the company. Areas of assignment may include, customer complaints and product failure investigations and corrective actions, Product/Process improvement efforts, documenting FAIR activities, writing and updating work instructions, inspections and checklists and quality system support. Work with manufacturing team to analyze problems and opportunities and plan for improvements. Supplier identification, approval, and support. Create/review/approve DHF, DMR, DHR documents and records. Provide quality assurance support to company functions with a focus on process improvements and compliance to design controls in accordance with ISO 13485, ISO 14971, 21 CFR Part 820, MDD 93/42/EEC, EU MDR and MDSAP. This role has direct interaction with our internal customers as an active member of cross functional activities throughout the product lifecycle.
Essential Duties and Responsibilities: (Other duties may be assigned)
- Analyze OEM suppliers' technical specifications, drawings and process requirements, drafting of internal test instructions.
- Generate internal quality reports based on CAPA, complaints and yield. Propose and drive product/process improvement initiatives.
- Assist in quality audits including FDA, Notified Body and internal audits.
- Lead non-conformance, CAPA, and complaint investigations to closure per Quality System requirements. Owning of Non-Conformances (NCs) from Internal and External regulatory audits of the QMS, and other NCs. Taking charge of investigation of the root causes, proposing corrective and preventive actions and generation of timely responses and Non-conformance Report (NCRs). Coordinate the effectiveness check and CAPAs closures.
- Work with suppliers, BMI and UMT's Supply Chain department to improve overall performance, including issuing and managing of Supplier Corrective Action Requests (SCARs) to closure, approving and maintenance of supplier files, and Approved Supplier List (ASL).
- Maintain metrics to evaluate process performance and work with manufacturing to ensure that expectations are met.
- Coordinate PPQP activities (pFMEA, CP, Capability reports, etc.).
- Interface with customers and suppliers regarding product problems or issues with assembly.
- Ensure compliance of Design Controls and Risk Management to FDA QSR, FDA guidance's, and applicable standards for new product development and design changes to existing products.
- Serve as QA technical resource and/or lead for requirements, risk, design verification and validation, process validation, usability engineering, statistical analysis, Design Transfer, etc. including Biocompatibility and Packaging/Ship Testing.
- Ensure compliance for Design Controls, Risk Management, and Design History Files to FDA QSR and applicable standards such as ISO 13485, IEC 62304, IEC 62366 and IEC 60601.
- Draft Design Verification and Validation Test Protocols, Methods and Reports. Experienced in determining test sample sizes using statistical techniques
- Create/Update Inspection method and checklists, including documenting procedures, work instructions, procuring/creating tooling and fixtures, performing measurements, and personnel training.
- Provide sustaining support for current production activities.
- Analyze and trend post-market surveillance data.
- Manage documentation on all recalls, product safety issues, field actions and failures to health authorities as required.
- Undertake additional responsibilities or activities as required by their supervisor
Education and/or Experience:
- Bachelor's degree or master's degree in, Engineering discipline is ideal
- Minimum of 5 years of experience working in medical device industry
- Background in electromechanical and software devices
- Working knowledge of CFR 820, ISO 13485, ISO 14971, IEC 62304, IEC 62366
- Working knowledge of sterilization, biocompatibility, and transit/shelf-life standards
- Experience with medical device Hardware testing (IEC 60601, IEC 60529)
- A Six Sigma/CQE certification or equivalent, e.g., ASQ CQE, CRE, CSQE, or CQA certification preferred.
- Must have a solid understanding of statistical processes and techniques
- Understanding of software development lifecycle and software configuration management
- Experience in conducting root cause investigations
- Must work well within a team
- Must be able to accomplish objectives with minimal supervision
- Ability to interpret a variety of instructions.
- Ability to troubleshoot issues for components, materials, tools, SW programs, equipment, and Electrical/Electronic Test.
- Excellent analytical and problem-solving skills. Specific training and demonstrated success in applying quality problem solving method, such as fishbone diagrams, 5 whys, FMEA, process capability analysis, hypothesis testing, DoE, SPC, DMAIC etc.
- Electrical testing experience - an advantage.
- Effective multitasking, organization and prioritization skills.
- Ability to work effectively with frequent shifts in direction.