Sr Quality Engineer

Kelly Science, Engineering, Technology, and Telecom a managed solution provider and business unit of Kelly Services, is currently seeking a Sr Quality Engineer for a long-term engagement at one of our Global Medical Device Robotics & Digital Solutions clients in Santa Clara, CA.

A global leader in surgery with products and solutions found in almost every operating room around the world.

This role is a full-time, fully benefited position. As a Kelly employee in this group you will be eligible for 50% paid Medical & Dental, 401K and a variety of other benefits to choose from.

You will also be eligible for paid time off, including holiday, vacation, and sick / personal time. All Kelly employees receive annual performance reviews.

Robotics & Digital Solutions is part of a global leader in surgery with products and solutions found in almost every operating room around the world.

They have made significant contributions to surgery for more than 100 years from creating the first sutures to revolutionizing surgery with minimally invasive procedures.

Their continuing dedication to Shaping the Future of Surgery is built on our commitment to help address the world's most pressing healthcare issues and improve and save more lives.

Through surgical technologies and solutions including robotics, digital solutions, sutures, staplers, energy devices, trocars, and hemostats, and our commitment to treating serious medical conditions like obesity and cancer worldwide, we deliver innovation to make a life-changing impact.

Senior Quality Engineer

The Senior Quality Engineer will be responsible for providing quality engineering support for manufacturing. The ideal candidate should have experience supporting complex electro-mechanical, software-controlled systems for medical applications.

This individual will work with engineering teams within the company. This position requires knowledge of medical device regulatory environment (FDA, MDD, ISO 13485).

Candidates should also have knowledge and experience to support Design for Reliability and Manufacturability (DRM), Design for Six Sigma, Design for Lean Six Sigma, Testing requirements like TMV and test protocol development, and risk management per ISO 14971 and other standards like IEC60812 and AIAG.

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.
• Develops and implement 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, and 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.

Qualifications

Required :

• Bachelor’s degree in Science or Engineering, or a related field
• Minimum 5 years of quality engineering experience with medical devices
• 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 with ISO 13485 and 21 CFR 820

Important information : This position is recruited for by a remote Kelly office, not your local Kelly branch. Applicants must be legally permitted to work in the United States immediately and without employer sponsorship.