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Graham Personnel Serviceshttps://cdn.haleymarketing.com/templates/62762/logos/graham-personnel-services-social.pnghttp://www.grahamjobs.comhttp://www.grahamjobs.comUSD5500060000YEARtrue
Assist the Quality Manager in establishing and maintaining an effective QMS that complies with relevant regulations, such as FDA's Quality System Regulation (QSR) and ISO 13485 standards. This includes developing and implementing quality policies, procedures, and work instructions.
Ensures that all manufacturing processes and products meet the necessary regulatory requirements.
Drive continuous improvement efforts throughout the organization by establishing quality metrics, conducting data analysis, and identifying areas for improvement.
Collaborate with cross-functional teams to identify and mitigate risks associated with the design, manufacturing, and distribution of medical devices.
Oversee the Quality Inspectors, Quality Coordinator, and Supplier Quality workflow and scheduling.
Assisting, developing, and delivering training programs to ensure that employees understand and adhere to quality standards.
Conduct interviews of prospective Quality Inspectors.
Oversee the documentation of processes, procedures, and quality records, ensuring compliance with relevant standards and regulations.
Coordinate and participate in audits to ensure compliance with regulations and standards.
Investigate into non-conformances or complaints of products.
Perform other duties or task assigned by the Quality Manager.
Qualifications
Education
High School diploma or equivalent required
Associate’s or Bachelor’s degree in related field, preferred
Experience
Over 2 years of management experience in quality within a manufacturing environment.
Internal basic quality training
A good knowledge of Good Manufacturing Practices (GMP), FDA 21 CFR part 820, and ISO standards.
Ability to handle multiple tasks simultaneously.
Skill in organization and prioritization, and attention to details.
Strong communication and interpersonal skills to collaborate with various stakeholders.
Understanding of quality management systems.
Strong team player and leader with the ability to work across multiple functions and disciplines.
Must be able to effectively communicate ideas (verbally and in writing), be a self-starter and handle difficult reporting situations.
Familiarity with regulatory affairs principles and processes is beneficial. Understanding the requirements for regulatory submissions, post-market surveillance, and labeling is valuable in ensuring compliance and successful product launches.
A thorough understanding of medical device technologies, manufacturing processes, and relevant quality standards is necessary.
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