"Alerted.org

QUALITY CONSULTING GROUP, a leader in the pharmaceutical, biotech, medical devices, and manufacturing industry, is looking for a talented, highly motivated and enthusiastic to join our team. In this role, you’ll work with a highly enthusiastic team, contributing in a world-class manufacturing industry in Puerto Rico & USA.

Responsibilities:

+ Develops, implements, administers and certifies compliance policies, procedures, and practices.

+ Ensures alignment with legal and ethical standards of the organization.

+ Provides compliance advice, investigates complaints and verifies deficiencies are corrected.

+ Develops employee communication and training programs that focus on the elements of a companywide compliance program.

+ Enforces antibribery and anticompetition laws.

+ Analyses metrics and audits functional compliance program.

+ Maintains current knowledge of laws for financial, advertising and marketing reporting, regulations, and industry guidance that impact the company's compliance program.

Qualifications:

+ Bachelor’s degree in Science or Engineering

+ 8+ years of experience in the medical device industry, with a strong background in field corrective actions, CAPA, or product quality management.

+ Experience on Quality Systems & CAPA, Change Control and Validations.

+ Solid understanding of FDA regulations (21 CFR Part 820), ISO 13485, EU MDR, and other relevant medical device regulations.

+ Proven experience leading FCA and CAPA processes, ideally within a medical device or regulated industry.

+ Strong project management skills, with the ability to manage multiple priorities and deadlines.

+ Excellent problem-solving and analytical skills, with the ability to identify root causes and implement effective corrective actions.

+ Outstanding communication and interpersonal skills, capable of effectively working with cross-functional teams and external stakeholders.

+ Proficiency in Microsoft Office Suite and quality management systems (QMS).

+ Strong technical writing.

+ Administrative Shift

Quality Consulting Group, LLC is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.

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