Do you want to join an international team working to improve the future of healthcare? Do you want to improve the lives of millions of people? Our Client is a global healthcare company which, since its foundation in Barcelona in 1909, has been working to improve the health and well-being of people all over the world. Our four divisions - Bioscience, Diagnostic, Hospital and Bio Supplies - develop, produce and market innovative medicines, solutions and services in more than 100 countries and regions.
Responsible for ensuring compliance with applicable domestic and international standards and regulations through audits and systematic maintenance of effective quality systems. Ensures that deadlines are met on time and within budget. Quality interface with other departments and business or marketing partners. Work independently with minimal supervision and exercise judgment within the defined procedures and practices to determine appropriate actions.
location: San Diego, California
job type: Permanent
salary: $71,000 - 90,000 per year
work hours: 9 to 5
- Conducts compliance audits of more complex documentation and data and approve use of Design History Records, Device Master Records, Nonconformances, Document Changes, Validations and Change Controls.
- Demonstrates working knowledge of Quality Control, Manufacturing and Inventory processes to apply performing internal Audits.
- Serves as QA interface with limited responsibilities to other departments.
- Reviews Customer Notifications and prepare, approve & submit data packages for external customers.
- Executes internal and/or external audits in compliance with ISO 13485 and 21CFR820 requirements.
- Participates in 3rd Party Audits from regulatory bodies including the FDA, notified bodies and business partners.
- Assists in developing quality systems & make recommendations for improvements to existing Quality systems. Manages Internal Audit CAPAs when required.
- Approves compliance assessments & interfaces with other departments and business partners for complaints, investigations, etc.
- Assists in chairing meetings as appropriate such as Complaint Review Board (CRB), Material Review Board (MRB) and Product Quality Committee (PQC), Change Control Board (CCB), and other meetings.
- Prepares appropriate Agendas and meeting minutes with minimal supervision.
- Monitors the progress of items on the meeting Agendas and reports progress, as appropriate.
- Represents QA as an extended core team member on Core team and cross functional special project teams with minimal supervision.
- May conduct new employee quality system or procedural training and develop department training programs.
- Conducts technical troubleshooting activities & investigation analysis with minimal supervision.
- Performs technical support of QA Systems.
- Develops, maintains & reports department metrics, as needed.
- Reviews and assesses the appropriateness of document changes in accordance with internal procedure.
- Reviews and assesses change control, validation, and qualification documents, as applicable.
- Bachelor's degree (BA) or (BS) in a Biological or Chemical Science.
- Quality certification (from American Society for Quality or equivalent), is a plus.
- 2-5 years related quality experience.
- Working understanding of QSR & ISO 13485 requirements as an auditor.
- Working knowledge of QC, Manufacturing & Inventory processes
- Working knowledge of Microsoft Word, Excel, Power Point and related functions including the formulation of graphs.
- Organizational skills, attention to detail and ability to prioritize in a fast paced environment is essential.
- Must demonstrate initiative, balanced assertiveness, flexibility and team orientation.
skills: Quality Assurance, 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).
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.