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Senior Quality Engineer

Employer
Kelly Science, Engineering, Technology & Telecom
Location
Santa Clara, CA
Closing date
Sep 24, 2022

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Kelly Engineering, Outsourcing & Consulting Group (KellyOCG ), a managed solution provider and business unit of Kelly Services, Inc., is currently seeking a Sr Quality Engineer for a Hybrid project engagement at one of our global medical device powerhouse clients in Santa Clara, CA.

This role is a full-time, fully benefitted position . As a KellyOCG employee you will be eligible for 50% paid Medical, Dental and 401K along with a variety of other benefits to choose from. You'll also be eligible for paid time off, including holiday, vacation and sick/personal time . All KellyOCG employees receive annual performance reviews.

As a Sr Quality Engineer placed with KellyOCG you will be responsible for the following:
The Sr. 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 the 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.
* 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.
* 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, nonconformances, etc., in order 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., nonconformances, 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 FMEAs

Requirements
Education

* Degree in Science or Engineering , or a related field with a minimum of 5-7 years of quality engineering experience.
* Preferred experience with Minimally Invasive Surgical (MIS) device, capital equipment, software, and device preferred.
* Strong interpersonal, organizational, and verbal and written communication skills and the ability to work effectively as a team member.
* Proven ability to work effectively in a team environment through conflict resolution and negotiations.
* Advanced analytical and problem-solving skills.
* Ability to guide and mentor on the Use of Statistical Sampling Methods
* Ability to work in a regulated environment in compliance to ISO 13485 and 21 CFR 820.

Work Environment
This position operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, and photocopiers.
Physical Demands
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
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.
Position Type and Expected Hours of Work
This is a full-time position. Days and hours of work are flexible Monday through Friday, generally, 8:30 a.m. to 5:30 p.m. Occasional evening and weekend work may be required as job duties demand.

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 (F1 OPT cannot be considered for this position).
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