Quality Systems Spec

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PharmaLex is a highly successful and growing consulting company for the Healthcare industry around the world. PharmaLex offers professional development, plus a stimulating and collaborative work environment. We are committed to providing exciting career opportunities in an atmosphere that values trust, respect, teamwork, creative talent, enthusiasm, and diligence.

Job Description
Responsibilities may include the following and other duties may be assigned. Provides oversight for the development and maintenance of quality programs, systems, processes and procedures that ensure compliance with policies and that the performance and quality of services conform to established standards and agency guidelines. 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 company's mission globally.

• 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.
• Trackwise and MAP Agyle tools knowledge

Education Required:
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.