Quality Systems Specialist
hace 2 semanas
Job Title: Quality Systems Specialist
Job Description:
Pharmalex is a leading consulting company in the Healthcare industry, providing professional development and a stimulating work environment. The company is committed to providing exciting career opportunities and values teamwork, creative talent, and enthusiasm.
Responsibilities:
• Provides oversight for the development and maintenance of quality programs, systems, processes, and procedures to ensure compliance with policies and regulatory requirements.
• Provides expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and agency guidelines to assure compliance.
• Works directly with operating entities to provide process analyses oversight on a continuing basis to enforce requirements and meet guidelines.
• Leads audit and inspection preparation, resolution of audit and inspection findings, and liaises with auditing groups and inspectors through all stages of the audits.
• Coordinates legal requests in support of government investigations or litigations.
• Ensures the quality assurance programs and policies are maintained and modified regularly.
• Facilitates uniform standards worldwide and enables best practice sharing, thereby fostering the achievement of the company's mission globally.
Requirements:
• Strong understanding of global regulatory requirements for medical devices, including FDA regulations (e.g., 21CFR Part 820), ISO 13485, Medical Device Directive, and European Medical Device Regulation.
• Experience defining, driving, and implementing process improvement and functional excellence efforts.
• Strong organizational skills and time management skills Ability to multitask, support multiple projects, function globally, prioritize, conduct team meetings, and meet project deadlines.
• Proven experience in achieving results through influence management and motivating teams.
• Good communication (oral and written), presentation, and interpersonal skills.
• Ability to work in a team environment as well as independently A continuous improvement mindset Exhibits high degree of initiative and good judgment.
• Experience working with Change Control, CAPA, documentation, audit, and/or training.
Education:
• Bachelor's degree in Science, Engineering, or related field required with a minimum of 2 years of Quality Management Systems and medical device experience.
Pharmalex is an Equal Opportunity Employer.
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