CTG Quality Design Assurance Engineer 2 in Fremont, California

Title: Quality Design Assurance Engineer 2

Location: US-CA-Fremont

Job Number: 18203866

Come join us and grow your career with CTG! Apply now for immediate consideration for this exciting opportunity.

Job Title: Engineer 2 - Quality Design Assurance

Location: Fremont, CA

Duration: 8 months, W2 Contract

Required Experience / Education

  • Completed Bachelor's degree PLUS a minimum of five years’ current, related experience in Medical Device / Biologics/ IVD manufacturing

  • Completed Masters’ degree PLUS a minimum of two years’ current, related experience in Medical Device / Biologics/ IVD manufacturing

  • Strong working knowledge of FDA QSR, IVDD, Design Control requirements, and ISO 13485

Desired Experience (nice to have)

  • Hands on experience with equipment/process validations is ideal

  • Experience with sample size determination using statistical technique and process control is preferred but not required

Job Summary / General Duties

  • Serve as Core team member on New Product Development projects to ensure compliance with Design Controls per ISO 13485 and FDA QSR

  • Develop and/or implement quality planning techniques in a medical design/manufacturing environment for new product introductions

  • Use statistical and risk management techniques for design and manufacturing and medical device industries

  • Participate in Design Reviews and identify improvements based on relevant risk analysis, past manufacturing experience, and Marketing/Customers’ specifications/requirements for products

  • Establish and participate in supplier qualification/development activities to ensure that products meet design and manufacturing requirements as part of Design Transfer

  • Advise and evaluate product verification/validation as well as equipment, process and material qualification/validation activities

  • Evaluate and implement protocols and methods (including SOP’s) to ensure that incoming material and manufactured products are compliant with internal requirements as well as to Standards/regulations for worldwide distribution

  • Perform analysis of reports and production data to identify trends and recommend updates or changes to quality standards and procedures when necessary

  • Develop/Use Key Process Indicators to determine process effectiveness, identify areas for improvement, best practices, and drive continuous quality improvement

  • Lead cross-functional teams in the execution and reporting of quality improvement projects with a focus on overall process improvements, scrap reduction and supplier quality improvement

  • Active participation and support of the internal audit process

  • Drive corrective, preventive, and closure actions for project issues related to quality and/or test non-conformance

  • Work closely with production line and ensure all necessary controls are enforced to be compliant with ISO 13485 and FDA QSR requirements

Additional Information

  • No third party resumes accepted

  • Drug testing and/or other employment-related inquires may be conducted

  • W2 only, no C2C or 1099 arrangements available

  • Candidates must currently reside in USA or Canada

  • CTG is an Equal Employment Opportunity employer

  • CTG is an E-Verify Company

To be considered for this opportunity, please apply directly through our website by clicking the link below or email your MSWord version resume to Maurine.Mercer@ctg.com. Please reference CTG job number 18203866 when applying!

Qualifications:

CTG (NASDAQ: CTG) provides industry-specific IT services and solutions that address the business needs and challenges of clients in high-growth industries in North America and Western Europe. CTG also provides strategic staffing services for major technology companies and large corporations. Backed by more than 50 years of experience and proprietary methodologies, CTG has a proven track record of reliably delivering high-value, industry-specific staffing services and solutions to its clients. CTG has operations in North America, Western Europe, and India.

CTG's greatest asset is its people, and as such, we are committed to providing employees programs and processes to support their performance, hone their skills, and advance in their careers. This commitment is reflected by CTG being named a Best Places to Work in Healthcare company by Modern Healthcare (2013-2016) in North America, and a Best Workplace in the United Kingdom (2013), Belgium (since 2007), and Luxembourg (since 2011).

CTG will consider for employment all qualified applicants including those with criminal histories in a manner consistent with the requirements of all applicable local, state, and federal laws.

CTG is an Equal Opportunity/Affirmative Action Employer and strong advocate of workforce diversity. Minority/Female/Sexual Orientation/Gender Identity/Disability/Veteran.

Job: Quality Assurance (QA) / Quality Control (QC)