New Product Development Quality Engineer
Company: Katalyst Healthcares & Life Sciences
Posted on: November 25, 2022
- 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
- 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
- Addresses defect prevention through review of quality history,
supplier base controls, scrap analysis, process control techniques
- 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
- Participate in supplier selection process and component
specification reviews to ensure that purchased items meet
- 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
- 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
- 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
- Provide training and support for quality system processes and
quality engineering practices.
- 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
- 4-5 years' direct experience in a Product Development or
- 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
Keywords: Katalyst Healthcares & Life Sciences, Wilmington , New Product Development Quality Engineer, Engineering , Elkton, Delaware
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