Description
Description:The Senior Quality Engineer is responsible for the quality assurance of DFM product design and manufacturing process control. He/she serves as a Quality member on new product development (R&D) and provides technical support or leadership of quality deliverables during all product development phases.
- Use of statistical tools to facilitate design verification test sample size and test method validations
- Development and execution of protocols for verification and validation activities. Provide statistical sampling size determinations.
- Lead Risk Analysis (FEMECA-Design/Process) meetings and generate final reports and actions requirements.
- Coordinate the investigation and closure of Corrective Actions (CAPA) and NCMR's.
- Performs parametric and/or destructive physical analyses of failed parts in order to determine the root cause. Implements appropriate corrective action.
- Work on new product transfers and actively participate in the qualifications and validations of product/equipment and processes.
- Support manufacturing activities (process development, validations, etc).
- Review and approval of document changes (process and design).
- Assist R&D in test method development and conduct test method validation.
- Maintaining of supplier qualification and part receiving requirements (ASL, FAI, Supplier Evaluation, Supplier Auditing, etc).
- Participate on internal quality audits.
- Development and implementation of quality systems in compliance with FDA facility registration, ISO certification and CE marking
Skills/Experience:
Minimum Qualifications:
- Experience with medical instrumentation and disposables, in a regulatory environment (i.e. GMPs, ISO9001, EN46001, etc.)
- Working knowledge of basic quality systems regulations such as Quality Systems Requirements and ISO:13485.
- Proficient in knowledge of variety of testing equipment (including Instron, pin gages, snap gages, micrometer, caliper, etc).
- Working knowledge of fundamental quality and statistical tools including SPC, DOE, Six Sigma and proficient with statistical analysis and software
- Proficient with statistical analysis and software (SPC, Minitab, Excel Stat, Statease, etc).
Preferred Qualifications:
- 5+ years of medical device engineering experience - Class III experience preferred
- Technology transfer experience preferred
- ASQC Certified Quality Engineer preferred
Education:
Minimum Qualifications:
- Bachelor's degree in mechanical, materials, biomechanical engineering or life sciences