The Senior Quality System Specialist serves as the site lead for Quality System and Compliance for the Sunnyvale site.
Manage Sunnyvale's internal audit program. Perform internal quality system audits to evaluate the quality system for compliance with applicable regulations and standards, i.e. ISO 13485:2016, MDD and MDSAP. The candidate will lead the post-audit process to ensure corrective action activities are supported by the action owners through to effective implementation.
Act as the Quality System Analyst for Sunnyvale's CAPAs and perform the following tasks in CAPA Agile - create new CAPA, assign the CAPA champion, assign the required approvers, ensure the action plan is implemented and verified to be effective prior to closure, approve all CAPA phases, monitor overall CAPA activities, approve CAPA extension request.
Coordinate preparing and scheduling the monthly Sunnyvale CAB and bi-annual Management Review meetings and follow through the action items from these meetings.
Manage Sunnyvale's employee training program, ensure training curricula are up to date and are assigned to employees in Cornerstone accordingly, monitor site's compliance to training and take necessary corrective or preventive actions
Manage Sunnyvale's document control system; ensure creation, changes, distribution, and retention of records are compliant to QSR
Lead compliance mitigation activities i.e. incorporating corporate quality systems requirements into Sunnyvale's quality system procedures and managing the periodic reviews of Sunnyvale quality system procedures.
Lead inspection/audit readiness activities and manage/lead backroom during external inspection/audit.
5+ years medical device and or pharmaceutical industry experience is required
Bachelor's degree is required. A degree in a scientific discipline is preferred
Lead Auditor or Quality Auditor Certification i.e ASQ CQA.
High achiever, possessing at least 5 years Quality Systems experience within a medical device manufacturing setting.
Demonstrated compliance fluency as per Quality System Regulation (21 CFR 820), ISO 13485, and other applicable Quality System standards.
Superior knowledge/application of all Quality System elements, including Complaint handling, CAPA, Design Control, Validation Review.
Demonstrated audit and corrective action proficiency in the medical device, or pharmaceutical industry
Breadth of range of quality system exposure to products and processes, from disposables, mechanicals and electromechanical products, as well as high volume, high precision, electrical, assembly processes
Ability to develop evidence in support of audit findings and in participating as a contributor on quality system projects.
Ability to conduct interviews of and other personnel during audits and report audit data in an unbiased, clear, written technical audit report.
Must be able to work in a strong and diverse teamwork environment
Ability to lead an Audit team.
Ability to apply time management skills to remain highly organized while ensuring audit reports and other deliverables are provided to other functions on-time.
Strong technical writing abilities
Superior communication skills
We know that a company's success starts with its employees. We also know that an individual's success starts with the right career opportunity. As a Best of Staffing® Client and Talent leader, Aerotek's people-focused approach yields competitive advantage for our clients and rewarding careers for our contract employees. Since 1983, Aerotek has grown to become a leader in recruiting and staffing services. With more than 250 non-franchised offices, Aerotek's 8,000 internal employees serve more than 300,000 contract employees and 18,000 clients every year. Aerotek is an Allegis Group company, the global leader in talent solutions. Learn more at Aerotek.com.