Quality Assurance Compliance Specialist
2 months ago
Innovive is a consistently growing B2B manufacturing company serving the biomedical research industry. We value hard work and credit the team for our success. We are looking for a Quality Compliance Specialist. The Quality Compliance Specialist contributes to the success of Innovive through working with suppliers and customers, in addition to the engineering, operations, and supply chain teams. This position requires continuous communication to suppliers to drive design and process improvements as well as responding to customer feedback. This full-time position will support the Quality Manager with maintaining qualified suppliers and improvement of products. We value hard work and credit the team for our success.
Position Responsibilities:
- Work with suppliers and Supply Chain team to establish and maintain audit schedules for raw material and service vendors.
- Execute on-site and/or virtual audits of suppliers and third-party manufacturers to assure compliance with product specifications and ISO standards.
- Provide clear and factual feedback to suppliers in the form of written reports including observations and assessment of corrective and preventive actions to remediate gaps.
- Participate in/conduct audit activities including opening and closing meetings, establishment of agendas, and coordinating with auditing team members; can include coordination of travel accommodations.
- Be primary point of contact for Customer Service team for complaint management; act as lead for investigation, root cause analysis and for training and/or communication of issues to production or quality teams as needed.
- Prepare and submit required quality records and documentation for closure and filing of customer complaints.
- Be an active member of the internal audit team. Assist in the completion of process audits.
- Learn and become a point of contact for NetSuite development of quality based modules.
- Lend support and assistance to the Quality Manager with projects as needed; additional responsibilities to be developed after 1 year of tenure.
Qualifications & Skills:
- Critical thinking and problem solving skills.
- Attention to detail.
- Organizational, planning, and documentation skills.
- Strong written and verbal communication skills.
- Brings values and a sense of ownership to the position.
- Ability to take direction as well as initiative.
- Team work.
Education & Experience:
- Experience in quality or systems management.
- 5 or more years of relevant experience required.
- Experience in the FDA industry is a plus.
- Experience working with Google Suite is a plus.
Location: San Diego, CA
Compensation: Salary commensurate with experience and highly competitive within the industry.
Employment Type: Full-time, Exempt
Travel: Up to 25%
Benefits Offered: We offer excellent benefit packages and employee programs including paid time off, paid holidays, medical, dental, vision, life insurance, disability insurance, FSA or HSA, 401k with Company match, EAP, employee discounts, and a casual work environment with excellent career development opportunities.
About Innovive
At Innovive, we understand that our success and continued growth wouldn't be possible without a dedicated, passionate, hardworking, and talented team. If you relish the challenge, thrive on finding solutions, and like being a part of a fast-growing company that helps make other people’s lives better, we would love to hear from you
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San Diego, United States Innovive Full timeInnovive is a consistently growing B2B manufacturing company serving the biomedical research industry. We value hard work and credit the team for our success. We are looking for a Quality Compliance Specialist. The Quality Compliance Specialist contributes to the success of Innovive through working with suppliers and customers, in addition to the...
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