Quality Assurance Specialist
hace 4 semanas
Pharmalex is a leading consulting company for the Healthcare industry, offering professional development and a stimulating work environment. We are committed to providing exciting career opportunities in a collaborative atmosphere that values trust, respect, teamwork, creative talent, enthusiasm, and diligence.
Responsibilities:- Develop and maintain quality programs, systems, processes, and procedures to ensure compliance with policies and standards.
- Provide expertise in interpreting policies, regulations, and guidelines to ensure compliance.
- Work with operating entities to provide process analysis and oversight to enforce requirements and meet guidelines.
- Lead audit and inspection preparation, resolution of findings, and liaison with auditing groups and inspectors.
- Coordinate legal requests in support of government investigations or litigations.
- Ensure quality assurance programs and policies are maintained and modified regularly.
- Foster uniform standards worldwide and enable best practice sharing to achieve the company's mission globally.
Requirements:
- Strong understanding of global regulatory requirements for medical devices, including FDA regulations, ISO 13485, Medical Device Directive, and European Medical Device Regulation.
- Experience defining, driving, and implementing process improvement and functional excellence efforts.
- Strong organizational skills, time management skills, and ability to multitask, support multiple projects, and prioritize tasks.
- Proven experience in achieving results through influence management and motivating teams.
- Good communication, presentation, and interpersonal skills.
- Ability to work in a team environment and independently, with a continuous improvement mindset and high degree of initiative and good judgment.
- Experience working with Change Control, CAPA, documentation, audit, and/or training.
- Trackwise and MAP Agyle tools knowledge.
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. We are committed to diversity and inclusion in the workplace.
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