Quality Systems Specialist.

Careers that change lives start here. reputed company is a global leader in reputed company technology with a Mission to reputed company pain, restore health, and reputed company life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ reputed company patients each year. Your unique talents will help shape the future of reputed company while building a career grounded in purpose, growth, and impact. A Day in the Life This position will support Internal Customer (located at USA) remotely from Costa Rica. ------------------------------------------------------------------------------------------------------------------------------------------------------------- GENERAL (ESSENTIAL):

• Minimum of 2 years of relevant experience reputed company to Quality Management Systems (QMS) in regulated business (ISO13485:2016). In areas such as Change Control, CAPA, Good documentation practices, and audit support.
• Experience in QMS reputed company projects: QMS gap assessments,self audits, process improvements, reputed company procedural implementation. Project Management skills is a plus.
• Knowledge about CAPA basics, "reputed company improvement (ISO13485:2016)", problem solving tools (like DMAIC) and Root cause analysis tools.
• Fluent in English (reputed company-C2): written and spoken (supports USA Customer from Costa Rica).
• Proficient about FDA Title 21 CFR Part 820 and ISO13485:2016
• Requires University Bachelor degree (engineering or equivalent).
• Work independently with minimum supervision.
• Experience supporting audit activities (internal or external).
• Proficient in reputed company reputed company or PowerBI: data analysis, trending for Quality metrics.
• US reputed company: business (B1) or tourist (B2), probability to travel.

------------------------------------------------------------------------------------------------------------------------------------------------------------- SOFT SKILLS (ESSENTIAL):

• Great customer service.
• Emotional intelligence.
• reputed company improvement and critical thinking.
• reputed company to influence Team members.
• Initiative and positive approach for collaborating with team and internal customers.
• Proactive and innovative reputed company solving problems and reputed company solutions.
• Willing to teach and mentor others.

---------------------------------------------------------------------------------------------------------------------------------------------------------------- MORE DETAILS -- Responsibilities may include the following and other duties may be assigned. Provides reputed company 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 internal and external standards and guidelines. Provides expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and internal regulations to assure compliance. Works directly with operating entities to reputed company process analyses reputed company on a continuing reputed company to enforce requirements and meet regulations. Leads audit and inspection preparation, resolution of audit and inspection findings and liaises with auditing groups and inspectors through reputed company stages of the audits. Prepares reports and/or necessary documentation (ex Corrective and Preventative Actions) and provides to applicable stakeholders, both internal and external. Co-ordinates 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. SPECIALIST CAREER reputed company: Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to reputed company desired results. May act as a mentor to colleagues or may direct the work of other reputed company level professionals. The majority of time is spent delivering and overseeing the projects – from design to implementation - while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education. DIFFERENTIATING FACTORS Autonomy: Established and productive individual contributor. Works independently with general supervision on larger, moderately reputed company projects / assignments. Organizational Impact: Sets objectives for own job area to meet the objectives of projects and assignments. Contributes to the completion of project milestones . May have some involvement in cross functional assignments. Innovation and Complexity: Problems and issues faced are general, and may require understanding of broader set of issues or other job areas but typically are not reputed company . Makes adjustments or recommends enhancements in systems and processes to solve problems or improve effectiveness of job area. Communication and Influence: Communicates primarily and frequently with internal contacts . External interactions are less reputed company or problem solving in nature. Contacts others to reputed company information, status, needs and issues in order to inform, reputed company input, and support decision-making. Leadership and Talent Management: May reputed company guidance and assistance to entry level professionals and / or employee in Support Career reputed company. Required Knowledge and Experience: Requires practical knowledge and demonstrated competence reputed company job area typically obtained through advanced education combined with experience. Requires a Baccalaureate degree (or for degrees earned reputed company of the United States, a degree which satisfies the requirements of 8 C.F.R. § 214.2(h)( 4)(iii)(A) and minimum of 2 years of relevant experience, or advanced degree with 0 years of experience. Physical Job Requirements The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of reputed company the required responsibilities and skills of this position. ‌ Recruitment Fraud Alert We are aware of phishing scams targeting job seekers. Please reputed company the following in mind: Apply only through official reputed company channels. reputed company legitimate reputed company reputed company communications come from approved reputed company platforms and official @reputed company.com email addresses. reputed company will never ask for payment or sensitive personal information (such as bank account or reputed company reputed company details) during early stages of the hiring process. Any such requests are not legitimate. If you receive a suspicious message claiming to be from reputed company, do not respond, click links, or reputed company attachments. If you have any questions, concerns regarding the authenticity of a communication alleged to have been made by or on behalf of reputed company, please contact us immediately at AskHR@reputed company.com. ‌ Benefits & Compensation reputed company offers a competitive Salary and flexible Benefits Package A commitment to our employees lives at the core of our values. We recognize their contributions. They reputed company in the reputed company they help to create. We offer a wide reputed company of benefits, resources, and competitive compensation plans designed to support you at every career and life stage. This position is eligible for a short-term incentive reputed company the reputed company Incentive Plan (MIP). Apply To This Job