Stryker
Location
São Paulo, SP | Brazil
Job description
Are you interested in working for a global company where you can work across functions and on a wide-variety of projects? As a member of Stryker’s RA/QA team, that is exactly what you will do! Here, we provide our RA/QA team the opportunity to learn new things, as well as endless growth opportunities! If you are interested in working at one of the World’s Best Workplaces, apply now !
Need another reason to apply? Here are 10 reasons to join our Regulatory Affairs/Quality Assurance team:
Who we want:
– Detail-oriented process improvers. Critical thinkers who naturally see opportunities to develop and optimize work processes – finding ways to simplify, standardize and automate.
– Business-oriented evaluators. People who effectively interpret information to demonstrate the effects of business initiatives, regulation and industry trends for sales, management, and leadership teams.
– Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, data, and insights to drive continuous improvement in functions.
– Dedicated achievers. People who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations.
– Curious learners. People who seek out cutting-edge research and information to expand and enhance their ability to develop new ideas into reality.
What you will do:
Compliance
•Must conduct all businesses and affairs in compliance with the laws and the regulations, including with the Foreign Corrupt Practices Act (FCPA) and the Stryker Code of Conduct, in compliance with the highest ethical values.
Quality Assurance
•Collects, organizes, and maintains files on local, regional, and global QA intelligence.
•Identifies the need for new quality procedures, SOPs, and participates in development and implementation.
•Identifies opportunities for continuous improvement and supports those activities across QA LATAM.
•Responsible for all applicable procedures and process for vigilance for Stryker LATAM as distributor of medical devices, cosmetics and biocides, and where applicable pharmaceutical products.
•Develop and harmonize PMS practices across the LATAM RAQA division to ensure timely execution of all actions initiated by the manufacturer.
•Leads LATAM QA team/ Influence local QA teams as appropriate.
•Monitors team performance and takes action to keep the team on track by providing appropriate coaching and feedback to others.
•Team management and encouragement to ensure high performance in accordance with our values.
•Collaboratively works to set meaningful performance objectives and identify milestones for goal achievement.
•Act as QA LATAM Leader, reporting performance, risks and issues to local leadership teams and other Stryker leadership teams where applicable.
•Lead the development and deployment of new systems and procedures regionally.
•Supports continuous improvement activities across QA activities across QA LATAM.
•Define/set up & determine performance objectives, targets & KPIs across QA LATAM teams.
•Leads recruiting, selection, on-boarding, and development of talent across QA LATAM to increase performance.
•Maintains a high level of team engagement and collaboration across the QA LATAM.
•Leads integration of new acquisitions, ensuring QA systems integration within the local office and across LATAM dependent on integration strategy.
•Ensure appropriate Communication and treatment of failures associated with Product Complaints to Stryker Corporation and local Authorities.
•Support and lead CAPA process.
•Leads compliance audits in Quality Assurance and communicates the results.
•Support the Indirect Channels Qualification Process.
•Develop and maintain Quality Agreements in place.
•Supports International Stryker's Legal Manufacturers audits, providing current documentation related to QMS required, and respond questions to Leader Auditor related to Country activities.
•Ensure that recalls and PFA´s for Stryker products are communicated to regulatory agency according to the local regulations.
•Supports the process associated with the service and quality complaint systems to identify and implement corrective actions.
•Advise distributors and sales representatives to achieve company quality requirements by reviewing complaint investigations, communications to sales representatives and customers regarding complaint investigations, internal and regulatory Quality audits.
•Participate in the compliance of the internal audit program, analyze results and follow-up.
•Establish and supervise the application of procedures to approve or reject products. Ensure that the necessary corrective and preventive actions are implemented.
•Contribute to compliance with the applicable regulations in force.
•Correct and/or reduce the probability of recurrence of adverse incidents due to the use of medical devices.
•Report adverse incidents due to the use of medical devices to the corresponding authorities.
•Maintain an active knowledge of the status of pending procedures under revision.
•Plan Internal Audit annually, monitor report, monitor No Conformities and Action Plan activities, if necessary.
•Participate from Corporate Audit, preparing and monitoring action plan, if necessary.
•Lead and approve Global Procedures Change Controls and ensure appropriated assessment is conducted at local and regional SOPs.
What you need:
•BSc degree in relevant field required.
•Advanced English skills required.
•Advanced Spanish skills required.
•Master's Degree or equivalent desired.
•Lead auditor certification desired.
•Experience in certification and maintenance of ISO 9001:2015 and ISO 13485:2016 quality management systems desired.
Knowledge/Competencies
•Demonstrated project management and time management skills, writing, coordination, and execution of more complex QA items.
•Demonstrated knowledge and application of regulatory requirements, including Medical Device Directive, Quality System and Post Market Surveillance requirements, as well as other international requirements pertaining to the medical device industry.
•Demonstrated technical knowledge of medical device quality requirements.
•Demonstrated ability to effectively prioritize and manage multiple project workloads.
•Demonstrated ability to lead and develop employees and building effective teams.
•Demonstrated leadership skills.
•Experience with recruiting, hiring, and developing talent.
•Demonstrated process improvement skills.
•Demonstrated ability to manage complex and multi-region projects within a matrix environment.
•Demonstrated ability to collaborate effectively with and lead cross-functional teams
•Influence across the organization.
•Coordinate, support, and lead technical and scientific QA activities.
•Undertaking assignments that are broad in nature, requiring originality and ingenuity.
•Ability to take unreviewed action or decisions on business-critical matters.
•Clearly conveys information to peers, supervisors, and other stakeholders across the LATAM organization, Design Divisions and third-party distributors.
•Leads meetings with regulatory agencies, internal and external audits, and other stakeholders.
•Prepares briefings and other information documents.
•Communicates information and advises on QA requirements to other departments and business units.
•Engages in communication with regulators and other key stakeholders on both routine and business critical matters.
•Creates clarity and direction amid complexity and develops solutions for self, colleagues, and the organization.
•Seeks out diverse ideas, opinions, and insights, and applies them in the workplace.
•Connects and relates well with people who think and act differently than oneself.
•Embraces scrutiny and accepts feedback as opportunity to learn and improve.
•Preparation of QA metrics for reporting purposes.
•High attention to detail and process consciousness.
•Strong IT skills, including Microsoft Office.
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