Join a startup team that is advancing their life saving product to market as a Quality Engineer! This team is rapidly growing and is aiming to save a countless amount of lives! The Quality Engineer role will be responsible for leading support on Process Validation for internal and external processes. This is a direct hire opportunity. Candidates should have at least 4+ years in a similar role in a manufacturing environment, preferably in a medical device environment.
location: HUNTINGTON BEACH, California
job type: Permanent
salary: $90,000 - 98,000 per year
work hours: 8am to 4pm
education: Bachelors
responsibilities:
- Execute IQ/OQ/PQ for site equipment
- Develop and manage process performance qualification and test method validation
- Maintain compliance with ISO and GMP and develop/review all validation SOPs and protocols
- Lead support for internal and external regulatory audits
- Lead investigations into non-conformances and oversee CAPA implementation
- Collaborate with internal and external stakeholders to integrate validation into project lifecycles
- 4+ years of quality/validation engineering within medical devices
- Expertise in IQ/OQ/PQ, Process Validation & TMV
- Knowledge of ISO 13485, GMP & FDA 21
- Experience with validation software & statistical tools
- Medical, dental, vision
- PTO & Holiday pay
- Annual Bonus
qualifications:
- Experience level: Experienced
- Minimum 4 years of experience
- Education: Bachelors (required)
skills:
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: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).
This posting is open for thirty (30) days.
Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance.
Qualified applicants with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.
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.
