As Senior Quality Engineer you will be responsible for the successful implementation of projects and activities to define, design, develop and deliver new processes, quality improvement and change initiatives.
Primary Responsibilities (include, but are not limited to):
Provides Quality Engineering support for all products.
Applies knowledge of design control principles, statistics, process & systems validation, and quality engineering techniques to positively influence projects and manufacturing.
Executes Test Method Validation and Process Validation.
Ensures changes to products are developed and manufactured in accordance with applicable industry standards, regulatory requirements and customer requirements.
Utilizes quality tools to include Risk analysis FMEA, statistical techniques including six-sigma and DOE (design of experiments), root case analysis, reading and correcting drawings.
Navigates complex government regulations to include FDA & QSR requirements and guidance under 21 CFR820, ISO13485 and ISO14971.
Present technical data to groups within and outside the organization.
Develops, modifies, applies and maintains quality standards and protocol for processing materials into partially finished or finished materials product.
Collaborates with engineering and manufacturing functions to ensure quality standards are in place.
Devises and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment.
Designs or specifies inspection and testing mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications.
Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements.
Knowledge, Skills & Requirements:
Bachelor’s Degree required
Minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience
Master’s degree preferred • ASQ-CQE, CQA, CBA or equivalent certifications
Medical device experience; or experience in a regulated environment
Experience working with suppliers and/or contract manufacturers
Strong analytical skills
Excellent communication skills
Ability to work effectively within team and across functions