Post Market Quality Associate
A biotech manufacturing company in Sunnyvale, CA is looking for a Post Market Quality Associate to execute Quality Systems and Regulatory Compliance requirements in conjunction with Company, Business and Regulatory requirements. Coordinates Quality System / Regulatory Compliance (QS/RC) interactions, requirements and compliance activities interfacing with Technical Service, Technical Support and other customer support teams. Responsible for maintaining customer-facing and field activities including complaint handling, product investigations and field actions (corrections, recalls and event reporting) activities.
- Support integration of the Post Market Process into all facets of the QMS to include management controls, Complaint Handling, Corrective and Preventive Actions, and Risk Management.
- Support processing Customer Complaints in a compliant and timely manner.
- Assist in the reporting of all Reportable events to the applicable Regulatory Agency.
- Provide QS/RC input on continuous improvement of customer facing systems
- Support changes to QS/RC processes through timely analysis and completion of field reports, service requests and customer complaints
- Support Field Action Coordinator with any tasks necessary to support field actions and/or field corrections.
- Partner with Quality Systems to continuously evaluate and improve internal compliance systems
- Continuously review requirements and practices in customer-facing responsibilities to ensure compliance to business, customer and regulatory needs
- Support continuous improvement of the Cepheid quality system meeting both operational quality and regulatory requirements.
- Ensure compliance to 21CFR820, ISO 13485, and other quality systems regulations and regulatory standards, as applicable.
- Partner with marketing and distributors to ensure compliance with contractual requirements, especially related to product performance and patient safety.
- Suggest significant opportunities for improvement (cost, cycle time, quality, etc.) that are complex or involve multiple organizational areas.
- Identify potential problems, including ambiguous situations, by actively reviewing and analyzing internal and external factors. Assess the potential impact and/or applicability to other related areas. Recommend corrective action to mitigate problem and preventive action to ensure there is no recurrence.
- Prepare formal written reports/documents for distribution within work unit and regions.
Bachelor’s degree or equivalent in Molecular Biology, Biology, Chemistry or related scientific discipline with at least 2 years of experience in a fast paced regulatory/compliance/quality team ideally in a medical environment
Understanding of quality and QS/RC compliance requirements in relationship to product performance and customer expectation.
Strong knowledge of Quality, Regulatory Compliance, and operations systems and processes to include GMP and QSR requirements for medical devices. (ISO 13485, FDA’s QSRs, EU’s MDD, Canadian Regulations) is required.
Strong technical, analytical and organizational skills
Possess essential skills for prioritizing workload and responsibilities
Demonstrates an in-depth understanding of advanced technical/scientific principles that relate to multiple, diverse, and or complex product management
Interprets subjective and complex aspects of specific regulations and has thorough understanding of multiple sets of associated regulations.
Able to confidently deal with ambiguous issues and provide input towards suitable actions.
Strong written communication, interpersonal, negotiations and problem solving skills
Effective communicator of technical & non-technical information
Ability to work in a self-directed manner to see issues through to completion.
Exceptionally strong team player with excellent interpersonal, and experience working with end-users in a mentoring capacity
Proficient with the Microsoft Office suite.
- Official Quality/Compliance certificates
- LEAN Methodologies
- Experience in Complaint Handling
For more than forty years, Richmar Associates has connected talented job seekers with Silicon Valley businesses from start-ups to Fortune 500. We specialize in the temporary and direct placement services business. Based in the Silicon Valley, Richmar offers staffing solutions that include temporary, temp-to-hire, payroll service, vendor management and direct placement services to clients in the High-Tech Industry.
Richmar is an Equal Opportunity Employer.