Quality Control Manager
4 weeks ago
Job Title: Quality Control Manager
Job Summary:
We are seeking a highly skilled Quality Control Manager to join our team at Innova Solutions. As a Quality Control Manager, you will be responsible for ensuring the effectiveness and quality of product tested in Quality Control (QC) Lab, effective investigation and execution of the non-conforming material (NCMR) process, effective investigation and execution of the complaint handling process, and continuous improvement activities.
Responsibilities:
- Lead a team focused on the activities defined above
- Ensure the applicable tools, techniques, and methodologies are used according to the company's needs and applicable regulations
- Oversee the work of assigned team within the QC Lab including responsibilities on transfer, projects within manufacturing in collaboration with key stakeholders
- Manage project activities with the accountability for successful completion of all deliverables to the business and develop project plans, schedule, scope, and objectives
- Identify risks, develop mitigation strategies, define alternative solutions, resolve issues, and follow-up on action items in collaboration with cross-functional groups
- Plan and lead the execution of laboratory activities to support supply chain and processes in accordance with applicable regulations, standards and guidelines
- Lead in the monitoring and publishing of QC Lab metrics for the organization
- Facilitate team to ensure laboratory specific investigations are performed in compliance with quality and regulatory requirements
- Provide Quality Operations support in cross-functional workstreams leading to continuous improvement (e.g., Lean Six Sigma)
- Effectively transfer and implement the Complaint Handing process
- Oversee the timely and effective execution of the complaint investigations
- Lead in the monitoring and publishing of Complaint Process metrics for the organization
- Effectively execute the non-conforming material (NCMR) process
- Oversee the timely and effective execution of the NCMR investigations
- Lead in the monitoring and publishing of NCMR Process metrics for the organization
Qualifications:
- A Bachelor's degree in science or engineering discipline (mechanical, industrial, biomedical, chemical engineering, material/life science) is required
- At least 5 years' work experience in a regulated environment (medical devices/diagnostic instrumentation industry, pharmaceutical or biotechnology industry)
- Experience in modular automation/fully automated assembly processes, particularly those involving plastic injection molded parts, mechanical spring, with integrated/non-integrated testing
- Test method validation and transfer cGxP Know-How incl. regulations ISO 13485, FDA 21 CFR 820, MDD 93/42/EEC Statistical methods Attention to detail
About Innova Solutions:
Innova Solutions is a global technology and business transformation solutions company. We deliver strategic solutions to our clients, enabling them to operate as leaders within their fields. We are committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment.
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