job summary:
Leader in medical device manufacturing is looking for Quality Engineer in Dublin, CA for a contract role expected to last 12 months, possible extension, possible temp to perm. This role is responsible for quality support for manufacturing, servicing, and warehousing of manufactured products.
location: Dublin, California
job type: Contract
salary: $53.00 - 58.82 per hour
work hours: 8am to 5pm
education: Bachelors
responsibilities:
- Responsible for providing quality support for New Product Introduction (NPI) for organization manufactured products.
- Responsible for driving continual process improvements in responsible areas of the business utilizing tools such as SPC, Statistics, DOE.
- Review and approve changes made to product and processes and validation/qualification protocols and reports utilizing expertise in electronic change management systems, test method validations (TMV), V&V activities, IQ/OQ/PQ and mathematical concepts such as probability and statistical inference.
- Drive quality and manufacturing improvements to assure that processes are in a state of control.
- Develop and maintains effective relationships and integrate activities with other departments and suppliers (as needed).
- Review and approve changes made to product and processes and validation/qualification protocols and reports.
- Responsible for drafting and/or updating Quality Procedures for Quality Operations functions.
Skills:
- Proficiency in reading and interpreting mechanical drawings and GD&T.
- Knowledge of QSR and ISO 13485.
- Medical Device Auditor certification preferred.
- Problem solver.
- Self-directed.
- Competent using office software including Database management, MS Word, Excel, Internet Explorer, PowerPoint, and Outlook.
Education and Experience:
- Bachelors degree in engineering (mechanical, industrial, chemical, electrical), or other technical discipline, or advanced degree in other disciplines, or equivalent experience preferred.
- Minimum of 7 years of quality engineering experience in FDA regulated medical device manufacturing environment(s).
qualifications:
- Experience level: Experienced
- Education: Bachelors
skills:
QualityMedical DeviceSAP Applications Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.
Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including health, an incentive and recognition program, and 401K contribution (all benefits are based on eligibility).
Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance.
We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.
For certain assignments, Covid-19 vaccination and/or testing may be required by Randstad's client or applicable federal mandate, subject to approved medical or religious accommodations. Carefully review the job posting for details on vaccine/testing requirements or ask your Randstad representative for more information.