Quality Assurance (QA) Specialist

Company: DCN Diagnostics
Location: Carlsbad
Posted on: May 15, 2022

Job Description:

Job DescriptionSalary: Join the DCN DX team. We provide lateral flow assay design and development, manufacturing, and clinical research services to clients all over the world. We are known for providing high level development and consulting work, education, manufacturing, and production of POC products including lateral flow assay reagents. This is a unique document control position/QA reviewer, where one oversees draft documents in verification and validation and approved documents in manufacturing. The right candidate will have knowledge of and worked with ISO 9001 and ISO 13485. Extensive experience in cGMP and manufacturing environment and FDA Regulation 21 CFR 820. This is a fast-paced job and this position works with multiple program managers, the assay development team, and manufacturing.Duties and Responsibilities

• Manage all external registration requirements to ensure they are met. Liaise with external bodies on all matters relating to registration. Maintain and improve, in line with business needs
• Support project design history files in conjunction with the Project Leads and Project Managers.
• Ensure that all in-house systems and procedures are updated, revised and modified to meet the needs of external certification bodies
• Update quality documentation and communicate to carry forward lessons learned from quality concerns
• Ensure that all necessary systems and procedures are in place to satisfy all customer requirements and audits
• Introduce new systems and procedures where appropriate
• Train others in all aspects of the quality system and application of procedures
• Undertake regular internal and process audits of the QMS
• Ensure corrective actions are undertaken to address non conformities found
• Hold quarterly audit performance meetings within the business and with Certification Bodies
• Manage the nonconformity and deviation program and associated tracking logs
• Train and lead employees to perform strong investigations and risk assessments in associated NCMR, Deviation, and Project files
• Provide detailed analysis of nonconformities
• Ensure ongoing compliance with the Quality Management System (ISO13485:2016/ISO9001:2015)
• Attend various meetings and action/communicate instructions
• Produce written reports and make presentations
• Identify business improvement opportunities within the organization
• Develop, implement and manage key performance indicators (KPIs) for each area of responsibility
• Set department objectives/KPIs and review and assess ongoing performance of direct reports
• Ensure KPIs are met by working to the overall plan, including management of, and reporting
• Report on achievement of targets and identify any actions requiredRelationship Management· Develop and maintain strong relationships with internal and external stakeholders to ensure optimal performance· Work collaboratively, negotiate and engage with key stakeholders to facilitate delivery and compliance with the quality strategy· Liaise and communicate with other departments, customers, suppliers and other service providers· Work as part of the Management team to share ideas and improve operation, recommending, supporting and implementing continuous improvement activities and process and procedure improvements to optimize results and improve quality of delivery, in line with quality standards requirements delivery in line with Company and Customer requirements· Communicate with personnel at all levels, internally and externally to the Company, in relation to Quality matters Requirements
  • Maintain confidentiality
  • Detail-oriented and meticulous work ethic
  • Extremely organized and efficient, expert data organizer
  • Proven skill for creating and implementing controlled document processes
  • Work well under pressure and have strong stress management skills
  • Strong oral and written communication skills
  • Proclivity for catching errors and enacting appropriate changes
  • Outstanding time-management; able to prioritize and delegate tasks
  • Ability to manage a variety of cross-functional team members
  • Strong interpersonal skills
  • Excellent analytical ability
  • Archival experienceQualifications
    • Bachelor's degree in science, or related scientific field
    • 5+ years of relevant experience
    • Extensive experience with ISO 9001 and ISO 13485 in design and manufacturing
    • Extensive experience in cGMP and manufacturing environments, preferred.
    • Internal auditing experience preferred
    • Proficient in EXCEL and/or other document management software and web-based tools
    • Skilled user of Adobe and Microsoft Suite

Keywords: DCN Diagnostics, San Diego , Quality Assurance (QA) Specialist, Other , Carlsbad, California