Sr. Quality Assurance Specialist

AccuMedical USA, Inc.

is looking for a Sr.

Quality Assurance Specialist to join our innovative and dynamic team in Costa Mesa, California.AccuMedical is focused on developing innovative therapies for neurovascular products that will address global unmet medical conditions and patient needs.

As a thriving small company with a multi-national team, we work in a fast-paced international environment, empowering our team members to take initiative, make decisions and lead with opportunities to excel and grow in their expert fields.

We foster a work
– life balance with dedication to the wellness of our employees.Essential Responsibilities of Sr.

Quality Assurance Specialist include:Support in effective maintenance of QMS for continuous improvements and suitability by complying with 21 CFR 820 (QSR) and ISO 13485:2016.Participate or lead in the development, revision and implementation of policies, procedures, work instructions and quality documents per federal and state regulations as well as international standards.Participate in and support with planning, scheduling, and conducting internal quality assurance audits of the processes, procedures and controls employed in the design, performance and analysis of product design development.Support external audit activities including supplier management audits.Monitor internal and external audit non-conformances and perform trend analysis.Support regulatory intelligence monitoring of new regulations and standards that apply to AccuMedical products and processes, as well as performing gap analysis of the change impacts.Facilitate the full life cycle document change order (DCO) management by processing the quality documents by reviewing, editing, formatting, notifying approval status, distributing, archiving, maintaining document properties (meta data) and planning training per document control procedure and templates.Ensure that clinical studies, including animal studies, are conducted and analyzed in compliance with the designated study protocols and procedures.Review of batch production records and release of lots as well as completed quality records, including receiving inspections and FAI.Oversee the performance and maintenance of NCR, compliant, CAPA and/or SCAR.Support with the creation and maintenance of DMR by collaborating with the R&D team and the Quality Engineers.Participate in risk management activities and maintenance of risk filesAssist in the preparation for the annual Management Review Meeting and creating quality matrices.Serve as a Quality Representative on cross-functional and multi-site teams.Perform other duties as assigned by management.Education and Experience:Must be eligible to work in the U.S.

and not require visa sponsorship.Bachelor’s Degree in a Life Sciences discipline, plus a minimum of 6 years of experience required in medical devices; or Master’s Degree in Engineering or another Scientific discipline plus minimum of 5 years of experience required in medical devices.Experience in implementing and maintain QMS per FDA 21 CFR 820 (QSR) and ISO 13485:2016.Have working knowledge of ISO standards (ISO 9001, ISO 13485, ISO 14975, ISO/TR 24971/2020).Must be knowledgeable in EU MDD/MDR and U.S.

FDC Act.Prefer Class II and Class III experience.Experience in writing technical documentsHave working knowledge and understanding of statistical techniquesHave strong technical writing, documentation, communication and interpersonal relationship skillsSix Sigma Green/Black belt preferredJob Type: Full-timePay: $80,000.00
– $130,000.00 per yearBenefits:401(k)401(k) matchingDental insuranceHealth insurancePaid time offVision insuranceSchedule:Monday to FridayEducation:Bachelor’s (Preferred)Experience:Medical Device: 5 years (Preferred)Shift availability:Day Shift (Preferred)Work Location: One location by Jobble