Step out of your comfort zone, excel and redefine the limits of what is possible. That’s just what our employees are doing every single day – in order to set the pace through our innovations and enable outstanding achievements. After all, behind every successful company are many great fascinating people.
To assist in maintaining Quality Assurance and Control practices in adherence to the Food and Drug Administration (FDA) regulations for the Quality System Regulation and for ISO 13485 standards, the QA Specialist is responsible for managing complaint handling, returned goods tracking, and reporting requirements. The QA Specialist will be responsible for working with Engineering, Manufacturing and Quality Assurance to coordinate the activities required for investigation including failure analysis, nonconformance and CAPA related to complaints. The position requires reporting returns to regulatory agencies as required and close investigations within appropriate timeframes.
QA Specialist
Ontario, CA
ESSENTIAL DUTIES AND RESPONSIBILITIES :
• Evaluate, investigate, and resolve complaints while also analyzing complaint data and gathering additional information as needed.
• Manage the complaint investigation process end-to-end.
• Work with other teams in a collaborative environment to complete the end-to-end complaints process in a highly regulated environment.
• Document product return and/or complaints as well as the results of investigations in a timely manner.
• Interface with customers and internal employees for reporting of complaints and returned goods.
• Document the analyses of product complaints for trends and identification of potential corrective or preventive actions.
• Report product complaints to appropriate regulatory agencies as required.
• Serve as a member of the internal audit team and implement/assist in implementing corrective and preventive actions.
• Recommend improvements in quality system to ensure that the quality system is efficient and effective controls are in place to minimize risk.
• Complete projects in a timely manner and consistent with corporate objectives.
• Manage the complaint investigation process end-to-end.
• Work with other teams in a collaborative environment to complete the end-to-end complaints process in a highly regulated environment.
• Document product return and/or complaints as well as the results of investigations in a timely manner.
• Interface with customers and internal employees for reporting of complaints and returned goods.
• Document the analyses of product complaints for trends and identification of potential corrective or preventive actions.
• Report product complaints to appropriate regulatory agencies as required.
• Serve as a member of the internal audit team and implement/assist in implementing corrective and preventive actions.
• Recommend improvements in quality system to ensure that the quality system is efficient and effective controls are in place to minimize risk.
• Complete projects in a timely manner and consistent with corporate objectives.
QUALIFICATIONS:
• H.S. Diploma with 3+ years relevant related experience
• Bachelor’s degree in engineering, clinical sciences, related sciences is preferred.
• 1+ year of post-market complaints experience in a medically regulated industry with an understanding of appropriate global medical device regulations, requirements, and standards such as ISO 13485 and FDA QSR.
• Medical Device and or other regulated industry (Pharma, IVD,) preferred.
• Must be able to work as a team to gather information needed to understand and solve problems
• Experience in Technical Writing
• Experience with creation and writing procedures or policies
• Advanced computer skills preferred
• Quality Management software knowledge preferred
• Bachelor’s degree in engineering, clinical sciences, related sciences is preferred.
• 1+ year of post-market complaints experience in a medically regulated industry with an understanding of appropriate global medical device regulations, requirements, and standards such as ISO 13485 and FDA QSR.
• Medical Device and or other regulated industry (Pharma, IVD,) preferred.
• Must be able to work as a team to gather information needed to understand and solve problems
• Experience in Technical Writing
• Experience with creation and writing procedures or policies
• Advanced computer skills preferred
• Quality Management software knowledge preferred
In a spacious modern setting full of opportunities for further development, ZEISS employees work in a place where expert knowledge and team spirit reign supreme. All of this is supported by a special ownership structure and the long-term goal of the Carl Zeiss Foundation: to bring science and society into the future together.
Join us today. Inspire people tomorrow.
Diversity is a part of ZEISS. We look forward to receiving your application regardless of gender, nationality, ethnic and social origin, religion, philosophy of life, disability, age, sexual orientation or identity.
Apply now! It takes less than 10 minutes.
Join us today. Inspire people tomorrow.
Diversity is a part of ZEISS. We look forward to receiving your application regardless of gender, nationality, ethnic and social origin, religion, philosophy of life, disability, age, sexual orientation or identity.
Apply now! It takes less than 10 minutes.
