5 часов назад
Quality Systems Spec
Вакансия из Hirify Global, списка международных tech-компанийДля мэтча и отклика нужен Plus
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Quality Systems Spec (Medical Devices): Maintaining and continuously improving quality management systems for compliance with internal procedures and external regulatory requirements with an accent on document control, audits, CAPA, complaints, training, and quality records. Focus on preparing for inspections, resolving audit findings, interpreting regulations, and driving quality improvements across cross-functional teams.
Location: Juncos, Puerto Rico, United States of America; onsite
Company
develops healthcare technologies designed to alleviate pain, restore health, and extend life.
What you will do
- Maintain and continuously improve quality management programs, systems, processes, and procedures.
- Interpret internal policies and external regulatory requirements to support compliance.
- Analyze operating processes and oversee adherence to applicable requirements.
- Lead audit and inspection preparation, finding resolution, and communication with auditors and inspectors.
- Prepare corrective and preventive action documentation and quality reports for internal and external stakeholders.
- Coordinate legal requests related to government investigations or litigation and support consistent quality standards worldwide.
Requirements
- Baccalaureate degree and at least 2 years of relevant experience, or an advanced degree with no experience.
- Unrestricted U.S. work authorization is required at the time of hire and throughout employment.
- Degrees earned outside the United States must satisfy the applicable U.S. regulatory requirements stated in the posting.
- Ability to work with quality systems, regulatory requirements, audits, documentation, and cross-functional stakeholders.
Nice to have
- Quality systems experience in medical devices, pharmaceuticals, manufacturing, or another regulated industry.
- Knowledge of ISO 13485, FDA 21 CFR Part 820, or GMP requirements.
- Experience with audits, CAPA, document control, deviations, change control, complaints, quality tools, or QMS systems.
- Ability to analyze data, prepare quality reports, and collaborate effectively across functions.
- Intermediate to advanced English proficiency, if required by the role.
Culture & Benefits
- Employment with a global healthcare technology company operating across more than 150 countries.
- Competitive salary and flexible benefits package.
- Eligibility for the Incentive Plan short-term incentive.
- Equal employment opportunity and reasonable workplace accommodations.
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