Location : Bogota, Capital District, Colombia
Job Category : Quality & Regulatory
Job # : 4678
At Zimmer Biomet, we believe in pushing the boundaries of innovation and driving our mission forward. As a global medical technology leader for nearly 100 years, a patient’s mobility is enhanced by a Zimmer Biomet product or technology every 8 seconds.
As a Zimmer Biomet team member, you will share in our commitment to providing mobility and renewed life to people around the world. To support our talent team, we focus on development opportunities, robust employee resource groups (ERGs), a flexible working environment, location specific competitive total rewards, wellness incentives and a culture of recognition and performance awards. We are committed to creating an environment where every team member feels included, respected, empowered and recognised.
What You Can Expect
Responsible for facilitating Corrective Action Preventive Action (CAPA) investigations in order to solve quality related problems. Resolve issues by identifying and applying solutions from acquired technical experience and guided precedents. Assist in planning and fulfilling investigation tasks, implementation tasks, and verification of effectiveness tasks by identifying and organizing activities into time dependent sequencing with realistic timelines. Ensure thorough documentation of all CAPA procedural requirements. Work effectively/productively with all departments by developing a team atmosphere. Responsible for ensuring CAPA files are audit ready. Interacts with many different functional departments, suppliers, and experts outside Zimmer to implement Zimmer Quality goals.
- Provides coaching for CAPA investigation from initiation through containment, root cause analysis, implementation, and verification of effectiveness.
- Provides facilitation and coaching on the problem solving process and challenges technical content.
- Interfaces with CAPA owners/teams to coach and facilitate progression through CAPA process.
- Assists with risk analysis of issue and ensures proper containment actions are applied.
- Verifies all procedural CAPA requirements are met.
- Assists to identify and escalate resource constraints/requirements, as applicable.
- Reviews CAPA files to ensure the files are audit ready, clearly tell the story, contain all required objective evidence, etc.
- Other quality tasks, as requested.
- Ability to work within a team environment and build relationships outside of the department
- Strong interpersonal and conflict resolution skills.
- Demonstrated CAPA experience
- Detail oriented
- Ability to deliver, meet deadlines and have results orientation.
- Able to communicate both orally and in written form to multiple levels of the company.
- Strong technical writing skills
- Microsoft Office Suite, expert knowledge of root cause analysis, and understanding of QSR/ISO regulations.
- Knowledge of statistics, process control, and process capability a plus
- English proficiency at a C1 (Advanced) level is required.
- Bachelor’s degree in engineering or an equivalent field.
- Proven Corporate CAPA experience within the Medical Devices industry is essential.
- Minimum of 5 years of experience in Quality and Corporate CAPA within the medical devices sector, with a demonstrated ability to lead, implement, analyze, and execute hands-on end-to-end CAPA processes.
- Strong knowledge of quality standards, including ISO 13485, is required.
- Experience working with global teams, particularly across North America (NAM) and Latin America (LATAM).
- Certifications such as CQE (Certified Quality Engineer) or CRE (Certified Reliability Engineer) from the American Society for Quality (ASQ) are considered a strong plus.
- A combination of education and relevant experience may be considered in evaluating qualifications.
Kindly ensure your resume is in English when applying, as applications in other languages cannot be considered.
EOE/M/F/Vet/Disability