Quality Operations Specialist I - Randstad USA

job summary:

As the largest staffing and recruitment agency in the world, we can commit to finding you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Utilizing a recruiter for your job search gives you access to a large network of top employers as well as detailed information about hundreds of positions. We supply prestigious life sciences and biopharma companies with job seekers like you to achieve their business goals. If you're looking for a position where you can serve as an asset to your company while making a difference in others' lives, we have the ideal position for you!

 
location: Irvine, California
job type: Contract
salary: $30 - 36 per hour
work hours: 9 to 5
education: Bachelors
 
responsibilities:

• Review and investigate assigned technical and clinical customer complaints. Perform technical investigations and document results per established procedures and timelines.
• Performs hands-on troubleshooting of customer returned devices and manufacturing nonconformities and completes associated technical documentation
• Assist complaint intake group through review and verification of initial complaint coding.
• Monitor post-market and manufacturing product performance through evaluation and trending of customer complaints, service calls, and manufacturing rejections. Ensure that appropriate corrective actions are implemented to address the root cause of trending issues.
• Supports quality functions pertaining to manufacturing line support and maintenance, including SAP.
• Support and coordinate product/process improvements through collaboration with cross-functional teams (Quality, Manufacturing, R&D, Supply Chain, Finance, etc).
• Ensure compliance with the company's Quality System policies and procedures and applicable external requirements and standards, including FDA, ISO 13485, and other worldwide regulatory agencies pertaining to medical devices

 
qualifications:

Must Haves:

• Bachelor's Degree in Biomedical, Natural Sciences, Engineering or related fields
• Years' Experience: 0-2 years
• Strong computer skills (including Excel)
• Demonstrated written and verbal communication skills

Preferred Qualifications:

• Familiarity with regulatory reporting requirements for medical devices (e.g. MDRs, Vigilance reports, etc);
• Familiarity with medical device complaint files and quality records;
• Knowledgeable of FDA regulations, 21 CFR part 820 and Part 803 and ISO 13485 standard.
• SAP preferred, but not required.

 
skills: Quality Assurance, MS-EXCEL, GMP (Good Manufacturing Practice)

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).

Applications accepted on ongoing basis until filled.


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.