Position Responsibilities

• Provide quality assurance support for manufacturing operations, or field/ product quality.
• Review and align manufacturing operational activities, such as Work instructions, Device History Records, Nonconformances, CAPA, RMA, and customer complaint investigations.
• Ensure that facilities, equipment, materials, processes and product readiness comply with cGMP practices.
• Review verification and engineering study reports and identify gaps for GMP compliance. Develop and execute strategies to close gaps in an efficient, technical, and compliant manner
• Serve as Quality representative on project teams for reviewing the new product design transfers and/ or line transfers.
• Identify and drive resolution of quality issues in Quality Management System and/ or manufacturing operations.
• Work with cross-functional teams to resolve operational quality issues.
• Trend, analyze and monitor key performance indicators, suggest improvements and escalate to supervisor/ management as necessary.
• Participate in customer complaints and work closely with cross-functional teams to investigation issue and ensure timely response to corporate/ customer.
• Work in accordance with procedures and integrated program plans to achieve and maintain the required level of product quality in preparation for FDA and ISO third party audits.
• Support product risk management activities and ensure quality and completeness of project design history files, validation packages, and change orders
• Coordinate issue resolution using a risk-based approach

Listed responsibilities are an essential, but not exhaustive list, of the usual duties associated with the position. Changes to individual responsibilities may occur due to business needs.

Position Requirements

• Bachelor's Degree in Biology, Biochemistry, Chemistry or equivalent field is preferred.
• 0-2 years of related experience in manufacturing, quality assurance, and/ or process validation in a regulated environment.
• Experience in the medical devices / IVD / biotech / pharmaceutical industry, or instrument hardware / software integration is an advantage.
• Good interpersonal, verbal and written communication skills.
• Familiar with 21 CFR 820 and ISO 13485 requirements.
• Familiar with words processing, spreadsheets and presentation tools.
• Familiar with failure investigation, technical report writing, data mining, trend analysis and statistical analysis.
• Adaptable to fast-paced, dynamic work environment with shifting demands
• Ability to operate with high level of independence to investigate and resolve compliance issues, lead projects, plan and implement improvements, and achieve goals.

All listed requirements are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional task and responsibilities.