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Senior Design Quality Engineer

Kelly Services


Location:
Belmont, CA
Date:
04/25/2018
2018-04-252018-05-24
Job Code:
US24R5JW_BH1433954
Categories:
  • job_category_engineering
Kelly Services
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Job Details

Job Title Senior Design Quality Engineer

Jobid US24R5JW_BH1433954

Location: Belmont, CA, 94002, USA

Description Senior Design Quality Engineer, Belmont, CA

As a Senior Design Quality Engineer you will provide design control and software/systems development guidance to Personalized Health Care software development teams and life cycle teams and be the single point representative for Design Quality Assurance activities on PHC software development project teams

**Job Title** : Senior Design Quality Engineer

**Work Location** : Belmont, CA

**Projected Duration** : 04/30/2018- 10/30/2018, Depending on workload and performance

**Shift** : 8 hour days / 5 days a week

**Pay Rate** : $35 to $54 an hour, Dependent on Experience

**Type** : Contract

**Responsibilities**

· Provide design control and software/systems development guidance to Personalized Health Care software development teams and life cycle teams and be the single point representative for Design Quality Assurance activities on PHC software development project teams. May be a core team member on a Life Cycle Team(s).

· Review and approve documentation consistent with design control regulations and guidance’s dealing with systems/software development, verification and validation practices and GPS design control policy and SOPs. Documentation to include but not limited to DHF documents such as customer requirements, product requirements, design and development plans and reports, verification and validation plans and reports, design transfer documents, labeling, risk management plans and reports, project plans and milestone documentation.

· Convey information from meetings and other communications to Quality Management to inform management of critical issues and to assure consistent feedback to teams which is in alignment with Quality Management policy.

· Author and, or review/approve Quality Plan and Report at milestones DI, DO and LD. Assist management in assessment of whether project has met requirements to pass milestone.

· Assist in the development of high level and departmental SOP’s governing or associated with design control activities/compliance.

**Qualifications**

· Bachelor’s or QE degree in Computer Science, Engineering or related scientific discipline (biomedical engineering, mechanical engineering, electrical engineering) or related biological science field, or equivalent combination of education and work-related experience in the area of software/systems development, verification and validation, required.

· Master's degree or QE in Computer Science, Engineering or related scientific discipline (biomedical engineering, mechanical engineering, electrical engineering) or related biological science field, or equivalent combination of education and work-related experience in the area of software/systems development, verification and validation, preferred.

· 3 years: Development and or QA experience of software, instrument systems under design controls and intermediate/advanced knowledge of in vitro diagnostic reagents, instruments and software products including nucleic acid based products related to RMS products and SOPs. Proven interactions with all Quality Management and other departments (Development, GCTA, Regulatory Affairs, and Operations). Strong track record of successful participation on cross functional project teams project teams.

· 5 years: Development and or QA experience of software, instrument systems under design controls and intermediate/advanced knowledge of in vitro diagnostic reagents, instruments and software products including nucleic acid based products related to RMS products and SOPs. Proven interactions with all Quality Management and other departments (Development, GCTA, Regulatory Affairs, and Operations). Strong track record of successful participation on cross functional project teams project teams.

· Strong working knowledge of QSR/cGMP, Design Controls, Systems/Software Development, Verification and Validation Principles and Practices, ISO 13485, EU IVD Directive, IEC 62304, Agile Development Methodologies.

Please APPLY, if interested.

After applying to the position, follow up with me by email or phone, John Wisner, Kelly Services Engineering Recruiter, at 630.424.3622, johw288@kellyservices.com. Thank you for your time and I look forward to working with you.

**Why Kelly** **®** **?**


Kelly puts you in charge of your career, with access to cutting edge projects and technologies inindustry leading organizations. Top companies throughout the world have trusted Kelly as a premiersource of engineering talent and services since 1965. And engineering job seekers know Kelly as a firmwith an unmatched reputation for quality, integrity and professionalism. Whether you seek the varietyand flexibility of working on short term project engagements, or prefer contract-to-hire or directhire placement with our clients, apply with Kelly to explore opportunities that suit your specificprofessional interests.

**AboutKelly Services** **®**

As a workforce advocate for over 70 years, we are proud to directly employ nearly 500,000 people around the world and have a role in connecting thousands more with work through our global network of talent suppliers and partners. Revenue in 2017 was $5.4 billion. Visit kellyservices.com and connect with us on Facebook, LinkedIn and Twitter .

Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females,Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and iscommitted to employing a diverse workforce. Equal Employment Opportunityis The Law.



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