Advanced Quality Engineer Job Description Template
Our company is looking for a Advanced Quality Engineer to join our team.
Responsibilities:
- Participate in collection of initial market feedback on new products and address early concerns;
- Evaluate predicate products for relevant quality issues tthat may impact new product development projects;
- Develop, review, and approve inspection plans, routers, and product drawings for new products;
- Lead investigation and health risk assessment for post-market events;
- Analyze and define critical quality attributes for product and process through risk analysis techniques;
- Engage in the design, development, manufacturing, and risk management activities for new product development projects;
- Support product design transfers to internal and/or external manufacturing facilities;
- Support quality system maintenance for the design control process by identifying and correcting deficiencies in procedures and practices;
- Develop quality assurance documentation to support new product development process and regulatory submissions.
Requirements:
- Strong analytical problem solving and decision making skills;
- Experience with LEAN Six Sigma methodology and use of quality/statistical tools;
- Bachelor’s degree in a Science, Technology, Engineering or Mathematics (STEM) discipline from an accredited institution;
- Ability to lead and be a contributing member of cross functional teams;
- Bachelor’s degree or higher (completed and verified prior to start) from an accredited institution;
- American Society for Quality (ASQ) certification such as Quality Engineer (CQE) or willingness to obtain;
- Experience in interacting with regulatory agencies (FDA, MoH, TUV, etc.) required;
- Strong in critical thinking and “outside the box” thinking;
- Demonstrated ability to successfully manage and complete projects in a matrix organization;
- Demonstrated ability to advocate for product excellence and quality;
- Prefer experience with medical device product development lifecycle, including risk management and design/process verification and validation;
- Thorough knowledge and understanding of US and International Medical Device Regulations;
- Highly developed problem-solving skills. Strong analytical skills;
- Experience in working in a compliance risk situation;
- Strong knowledge of Quality Concepts (e.g. CAPA, Audits, Statistics).