Sr Quality Systems Supv. (Quality Assurance)

Location: Juncos, Puerto Rico, United States of America. Unrestricted U.S. work authorization is required at the time of hire and throughout employment. U.S. work authorization sponsorship is offered only for Principal-level roles and above.

Company

Global healthcare technology company developing medical technologies intended to alleviate pain, restore health, and extend life.

What you will do

• Oversee daily quality assurance operations and provide leadership, coaching, and guidance to QA team members.
• Develop and maintain quality programs, systems, processes, and procedures aligned with internal and external standards.
• Lead audit and inspection preparation, coordinate responses, and support resolution of findings with auditors and inspectors.
• Prepare quality documentation, including corrective and preventive action records, for internal and external stakeholders.
• Analyze processes, monitor quality performance, identify quality risks, and support investigations and corrective actions.
• Coordinate legal requests related to government investigations or litigation and promote consistent quality standards worldwide.

Requirements

• Baccalaureate degree and at least 3 years of relevant experience, or an advanced degree and at least 1 year of relevant experience.
• Advanced knowledge of the quality assurance field gained through education and professional experience.
• Understanding of management practices including work scheduling, prioritization, coaching, and process execution.
• Unrestricted U.S. work authorization is required; sponsorship is not available for this role.
• For degrees earned outside the United States, the degree must satisfy the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A).

Nice to have

• Experience working with regulatory agencies.
• Green Belt certification.
• Knowledge of Kepner-Tregoe and DMAIC problem-solving techniques.
• Knowledge of statistical techniques and risk management standards.

Culture & Benefits

• Mission-driven work focused on improving patient health through medical technology.
• Competitive compensation and a flexible benefits package.
• Eligibility for the hirify.global Incentive Plan short-term incentive.
• Equal employment opportunity and reasonable accommodations for qualified individuals with disabilities.