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 focus on working with external suppliers to investigate and resolve non-conformance issues. This role will require some domestic travel. This is a direct hire opportunity. Candidates should have at least 5+ years of manufacturing engineering experience in medical devices. Some candidates may be eligible for relocation assistance.
location: HUNTINGTON BEACH, California
job type: Permanent
salary: $90,000 - 98,000 per year
work hours: 8am to 4pm
education: Bachelors
responsibilities:
- Lead Quality Investigations: Take the lead on supplier Nonconformance Reports (NCRs), from identifying the initial issue to determining the root cause and verifying corrective actions.
- Manage Supplier Relationships: Collaborate with suppliers to ensure timely resolution of quality issues and effective implementation of corrective and preventive actions (CAPA).
- Ensure Regulatory Compliance: Develop, author, and maintain comprehensive NCR documentation in compliance with ISO 13485, 21 CFR 820, and other applicable regulations.
- Conduct Audits: Perform on-site supplier audits and process inspections. You'll also provide technical guidance to help suppliers address non-conformances and support internal/external audits.
- Drive Continuous Improvement: Contribute to supplier evaluations and support follow-up on quality-related issues to enhance overall supplier performance.
- Collaborate Across Teams: Partner with R&D, Manufacturing, and Regulatory Affairs to ensure that all supplier-provided materials meet design and manufacturing requirements.
- Support Quality System Activities: Assist with the receiving and inspection of materials, manage quality records, and contribute to process validation and facility controls.
- 5+ years in medical device quality or manufacturing with 2+ years of at least class 2 experience
- Knowledge of ISO 13485, 21 CFR 820, and ISO 14971
- Medical, Dental, 401K, Profit Sharing and PTO/Holiday Pay
qualifications:
- Experience level: Experienced
- Minimum 5 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.
