POSITION SUMMARY: This position is responsible for identifying and mitigating regulatory product and business risks during product development, process development and validation, production, and post-market surveillance activities. Product Launch Quality Engineer is required to use risk management tools and quality engineering principles to quantify risks and take action to ensure seamless customer approval.
PRIMARY DUTIES & RESPONSIBILITES:
Provide advanced new product development support as part of a cross-departmental project team.
Participate or lead project team in risk management document review, specification evaluation, manufacturability review, tooling, and equipment development.
Assist with specification creation and aligning tolerances during development.
Ensure effective and efficient use of Quality Engineering techniques.
Participate in the development of DFMEA / PFMEA with strong skill set to drive project success.
Support and provide input to the product and process validation protocols referencing risk management, specifications, statistical techniques and acceptance criteria.
Oversee product/process validation execution.
Lead the documentation development of FAI or PPAP submission to the customer.
Lead product/process audit relevant to product launch process.
Thorough understanding and skillset utilizing Corrective/Preventive action methods.
Review and investigate customer returns for potential root cause.
Support manufacturing with product and process problem-solving as needed.
Project main point of contact with customer, internal team, and suppliers.
Create and communicate reports as required during project development and launch.
Other duties as assigned by Manager.
Bachelor's degree in engineering, manufacturing, business related field or extensive experience in quality engineering in lieu of formal degree.
Four to six years of experience in quality, engineering, manufacturing, or related area.
Working knowledge of regulatory and standards systems.
Experience in quality-related areas (metrology, laboratory controls, auditing, etc.)
Able to work independently and with project team to achieve product launch success.
Basic project management skills including the ability to track action items, owners and due dates.
Strong verbal and written communication.
Proficiency with PC Skills, Word, Excel, and PowerPoint.
Ability to travel as needed to visit other company or partner locations.
Knowledge of Quality Management System certification process and requirements.
Understanding and ability to use measurement devices for product measurement.
Ability to use various computer applications and software.
Ability to work with others jointly to accomplish company goals and objectives.
Strong problem-solving and investigation skills.
Strong communication skills, both verbal and written.
Ability to read blueprints and technical documents related to products, testing and standards.
Ability to adapt quickly to computer applications.
Able to use Microsoft Office products.
Able to schedule and conduct virtual group meetings in lieu of in-person format.
Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability or protected veteran status.