Quality Assurance Manager (US based)
Formal Educational Requirements
· Master in Science or equal through experience
· Min 5 years experience in a Quality function in a medical device/pharmaceutical company
· Respect deadlines
· Multi functional
· Stress resistant
· Knowledge of ISO standards: ISO 13485:2016; ISO 22716:2007; ISO 9001:2015
· Knowledge of international and regulatory regulations such as Regulation (EU) 2017/745 on Medical Devices
· Excellent knowledge of Good Manufacturing Practices (GMP), including the U.S. current good manufacturing practices required by the FDA and set forth in the Federal Food, Drug & Cosmetic Act or FDA regulations, including without limitation 21 C.F.R. Part 210 and 211 and all applicable national regulations
· Experience with CAPA and change control process, supplier management, management of a QMS
· Experience in a manufacturing environment
Expected Professional Attitude
· You have a mature, positive personality and love challenges. You are passionate and have strong organizational and analytical skills.
· You have a ‘can do’ & hands-on mentality. You think customer- and solution-oriented. You are stress resistant.
· You have a learning attitude: curious and interested.
· You are diplomatic, a goal-getter and above all, you are a team player. Through your excellent communication skills, you ensure optimal cooperation within the company with the other departments.
· Expertise in Quality Assurance: A QA Manager brings specialized knowledge and experience in quality assurance practices, regulations, and industry standards. They understand the intricacies of implementing a robust QMS and can ensure that it aligns with the specific requirements of Oystershell and the FDA.
· Oversight of Day-to-Day Operations: The QA Manager will be responsible for overseeing the daily activities related to quality assurance. This includes monitoring processes, identifying potential areas of improvement, releases, supplier management and implementing corrective and preventive actions as necessary. Their presence on a full-time basis ensures continuous monitoring and maintenance of the QMS.
· Compliance with FDA Guidelines: The FDA guidelines for QMS are subject to updates and changes over time. A full-time QA Manager can stay updated with the latest FDA regulations and ensure that the OCHI QMS adheres to these guidelines. This proactive approach minimizes the risk of non-compliance, potential regulatory issues, and penalties.
· Project Management: Implementing the Oystershell QMS within the OCHI organization is a significant undertaking. The QA Manager can take charge of this project, ensuring its successful execution. They can create and execute a comprehensive project plan, define timelines, allocate resources, manage stakeholders, and track progress. Their involvement in the project ensures a dedicated focus on QMS implementation, avoiding potential delays or oversights.
· Training and Documentation: A QA Manager can develop training programs to educate employees about the QMS and the new FDA guidelines. They can also establish standardized procedures, protocols, and documentation practices, ensuring consistency and traceability. By providing necessary training and maintaining accurate documentation, the QA Manager helps create a culture of quality throughout the organization.
· Continuous Improvement: Quality management is an ongoing process that requires continuous improvement. A full-time QA Manager can conduct regular audits, evaluate performance metrics, and identify areas for enhancement. They can drive initiatives to enhance process efficiency, product quality, and customer satisfaction, resulting in continuous improvement of the QMS.
Primary Responsibilities and Tasks
Release all stock keeping items (raw materials, packaging materials, end products, marketing materials)
Responsible for release of all stock keeping items
Daily contact with service suppliers that may have direct impact on the product quality and/or performance (manufacturing, testing, regulatory) (i.e. CMO)
Qualification & Evaluation of suppliers; including creation of yearly audit plan for the critical suppliers and performing the quality audits
Review and approve protocols, investigation reports, annual product reviews and other documents from CMOs.
Address and control Customer Specific Quality requirements
The QA Manager is responsible for follow-up and investigation of non-conformities. This includes non-conform products detected before and after delivery, Out-of-specifications(OOS) and deviations. This is also applicable for OOS/Deviations reported by the suppliers.
Customer service representative does the initial intake of the complaint and follow up.
If needed, request investigations, review and approve CMO investigations;
Create trend analysis reports of these consumer complaints.
CAPA (Corrective and preventive actions)
Responsible for initiation, investigation of CAPA and if needed execution of ‘Product related’ corrective and/or preventive actions.
Control of Changes
Review and approve CMO change controls and initiate a control of changes (product and material related) in the document management system.
Performing impact assessment and approval/Acceptance of proposed changes.
Follow up pending changes with all stakeholders.
Design transfer (New Product Development)
Supporting quality activities during transfer of validated design to subcontractor:
– Qualification of suppliers
– Final Quality approval of the specifications for raw materials & primary packaging and bulk (08-article) and primary packed (10-article) product
– Quality approval of the production files (bulk and primary packed product) and master batch records. In a later stage also the approval of final product production files.
– Supporting role during first batch production in close collaboration with R&D manager and Qualification & Validation Mgr
– Set up stability studies. The type of stability study and indicative parameters are determined together with the responsible R&D project leader.
– Quality approval of validation documentation (protocol and report) provided by the Qualification & Validation Mgr
– Participate in the FMEA risk analysis of the manufacturing process of the product
Provide training (on request) of Oystershell employees on the production related procedures.
Approval of (master) articles in the ERP system
QMS processes maintenance
Prepare, review and approve OCHI SOPs, and train where necessary to maintain compliance with regulatory requirements.
Responsible for the OCHI QMS processes: CAPA / Change Control / Deviations / Complaint Handling / document management in Document Management System
Reporting on QMS Performance (monthly KPI reports)
Schedule, perform and/or review GMP and Quality System Regulations audits at CMOs and suppliers.
Primary contact for external audits (FDA, customer, …)
· Responsible for Quality Agreements with suppliers and customers (new QA when there is a new supplier or customer and perform periodical review of existing QA).
· Create yearly quality plan and follow up.
· Perform Management Review Meetings (MRM)
· Responsible to create the yearly quality objectives together with the management team
· Support sales department with questionnaires and registration files
· Identify process bottlenecks and plan and implement quality optimization projects
· Coordination of Quality with other functional areas, such as regulatory, sales, Supply, procurement, sourcing, datamanagement and finance
If you are interested in joining the dynamic team of Oystershell, please send your CV and motivation letter to firstname.lastname@example.org. Response and confidentiality are guaranteed.
Please note that we only accept direct applications.