Senior Quality Engineer

2 weeks ago

Santa Clara, United States Katalyst Healthcares and Life Sciences Full time
Roles & Responsibilities :
•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 in compliance with requirements.
•May specialize in the areas of design, incoming material, production control, product evaluation and reliability, inventory control and/or research and development as they apply to product or process quality
•Apply and understand statistical methodologies, as appropriate, for conformity assessment and investigative activities to resolve potential product and quality system opportunities for improvement.
•Review equipment and process validations, changes, non-conformances, etc, to ensure compliance and assess the impact on product reliability, process capability and compliance status.
•Review and approve test method validation and stability plans and reports.
•Lead and/or participate in corrective/preventive action teams in resolving production, customer, and supplier issues (e.g., non-conformances, CAPA or CAPA activities, audit findings, complaint investigations, etc.).
•Leads process improvement efforts by identifying methods to capture quality metric data and by performing appropriate analysis methods to enhance sustaining product design
•Develops product quality plans, documents and systems by creating product specifications, quality specifications and quality plans in conjunction with other product development team members. May be responsible for creating risk analyses and FMEA's
•This position operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, and photocopiers.
•While performing the duties of this job, the employee is regularly required to attend meetings, observe in labs or the manufacturing area. The employee frequently is required to sit, stand or walk.
•Occasional evening and weekend work may be required as job duties demand.

Education & Qualifications:
•Bachelor's degree in Science or Engineering, or a related field
•Minimum 3-5 years quality engineering experience
•Experience supporting complex electro-mechanical, software-controlled systems for medical applications
•Experience with pFMEAs, Test Method Validations, Root Cause, CAPAs, Non-Conformance Management, and Process Validations
•Advanced analytical and problem-solving skills
•Ability to work in a regulated environment in compliance to ISO 13485 and 21 CFR 820

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