Contract position: A Process Engineer Consultant is needed for a leader in electronics, healthcare, and lighting in the Fremont, CA area. This position will guide and participate in test method validation, risk assessment, requirement development, protocol and validation report writing. No per diem available. No travel required. 1st shift position. Responsibilities for the Process Engineer
Requirements for the Process Engineer
- Guide and participate in bug testing, identification, and problem solving, oversees the validation process, the QMS system and participates in the Internal Quality Audits.
- Write and maintain FDA level validation protocols and reports. Support quality planning activities on new and existing programs.
- Investigate customer quality issues and requests. Interpret and implement ISO9000/13485 and FDA standards. Support internal audits. May require focus on CAPA execution in Operations.
- Bachelor's or Master's degree in Engineering with at least 12 years of professional experience.
- Firm understanding of IQ, OQ, PQ and Software Validation requirements and practices.
- Expertise in PFMEA, Gage R&R, test system and manufacturing software validation for medical devices within manufacturing environment.
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.
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.