New Product Development Quality Engineer
Responsibilities:
- Represent Quality on product development teams to ensure adherence to company quality procedures and applicable US and OUS regulatory requirements and standards.
- Provide focused quality engineering support and assume responsibility for timely and effective coordination and/or execution of assigned project activities
- Lead quality system development and implementation throughout product life cycle
- Provide oversight for internal and external metrology, incoming inspection, acceptance criteria, disposition of non-conforming materials, and measurement system evaluations.
- Assure that all applicable elements and product technical standards that are applicable to a design category are effectively incorporated into new designs and into changes to designs.
- Review and approve/reject technical transfer plans and reports from the design transfer perspective. Provide input to design and manufacturing documentation including material specifications, drawings, inspection procedures, and manufacturing procedures, to ensure that the resulting products can be adequately manufactured and tested
- Lead teams and ensure completion of Risk Management activities for new and/or modified products and processes which includes risk assessment occurs in the appropriate phase of the project, authoring risk management plans and reports, facilitating risk assessment activities with no guidance required.
- Leads cross functional team on how to documents changes, using a risk based approach for determining requirements.
- Lead master validation planning sessions for assigned projects.
- Addresses defect prevention through review of quality history, supplier base controls, scrap analysis, process control techniques and training.
- Acts as the Technical Specialist to Purchasing in supplier-related quality issues.
- Contribute to design input requirements from experience with previously reported problems from internal sources (non-conforming material reports, yield, rework) or external sources (customer complaints), competitive devices and/or other similar products
- Participate in supplier selection process and component specification reviews to ensure that purchased items meet specifications
- Develop and validate quality test methods.
- Establish effective corrective action plans. Lead in implementation of quality assurance plans, process controls, and CAPA systems designed to meet or exceed internal and external requirements.
- Acts as an effective leader or team member in supporting quality disciplines, decisions, and practices.
- Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
- Review and approve product and process qualification and validation and other change control related documentation.
- Generate internal quality documentation such as quality plans, standard operating procedures and inspection procedures.
- Participate in Product Review Boards. Identify non-conformance trends and develop technical investigation plans. Investigates and analyze customer/internal complaints.
- Performs analytical measurements and experiments to qualify or resolve product and process issues.
- Track quality trends and initiate action items to resolve issues. Manage assigned corrective actions.
- Monitor field quality and analyze field returns to determine root cause.
- Provide training and support for quality system processes and quality engineering practices.
Requirements:
- Requires a minimum of a 4-year degree in engineering, life sciences, or similar.
- Solid knowledge of engineering fundamentals and proven ability to apply this knowledge to new product development and manufacturing.
- 4-5 years' direct experience in a Product Development or R&D Organization
- Requires 3 to 6 years increasing responsibility and experience in a medical device quality assurance environment.
- Strong communication skills both verbal and written.
- Strong organizational skills as well as time management skills essential for project work.
- Self-motivating and able to balance multiple priorities and tight deadlines with minimal supervision
- Experience using quality tools and statistical programs like Minitab, risk assessment (FMEA), experimental design (DOE) and process improvement (SPC) is required.
- Excellent computer skills
- Strong writing, mathematics and statistics skills
- Demonstrated working knowledge of 21 CFR 820 (Quality Systems Medical Devices), ISO 13485, ISO14791, and other medical device related standards.