MITG The Minimally Invasive Therapies Group strives to enable earlier diagnosis, better treatment, faster complication-free recovery, and enhanced patient outcomes through less invasive surgical solutions.
A Day in the Life
SUMMARY OF POSITION :
The Compliance Specialist CAPA position. The role will be required to perform data analysis from Quality Management Systems to facilitate and support communication, management and action, achieving Key Performance Indicator goals and enabling efficient process operations related to Corrective and Preventive Actions (CAPA). In addition, the role will be required to engage, assist, and implement actions in response internal and external audits by compliance, regulatory and notified bodies. The position also requires participation in quality system process improvement initiatives. The role is expected to be the driver and agent for ensuring timeliness of processes and effectiveness throughout the Global Business Unit (GBU). This role may be GBU representative on the corporate council for quality system improvements and initiatives.
ESSENTIAL FUNCTIONS :
Demonstrate solid understanding of internal and applicable external policies, procedures and standards/regulations related to Quality Management Systems.
Proficient in corrective action methodologies such as, root cause analysis, 5 Whys, Cause Mapping, etc. Provide support to CAPA owners/champions throughout the organization. Works with action owners to achieve timely and effective CAPAs
Participate in audit preparedness to ensure accuracy and completeness of pertinent records and documentation. Assist in the coordination of document management for data analysis and data review processes for audit readiness.
Apply knowledge, develop processes, optimize processes, and suggest improvement to current processes as needed.
Prepares reports and/or necessary documentation (i.e: Corrective and Preventive Actions) and provides to applicable stakeholders, both internal and external.
Establishes and ensures linkages to other key quality systems and programs such as Management Review, Validation, Risk Management, Complaints, Design Controls, Technology Transfer, Production & Process Controls, External Manufacturing, Calibration, Preventive Maintenance, etc
Builds cross-functional and cross-departmental support.
Associate management representative supporting internal and external audits and regulatory interactions including:
Audit event coordination and support during on site audits
Notified body communication coordination and support
Audit issue resolution coordination ensuring satisfactory and timely closure
Quality data source collection, analysis, preparation and presentation for management review, and CAPA Action Board (CAB).
Drives owners and admins towards effective and timely corrective actions.
Experience managing multiple high priority projects at the same time.
Ability to drive results, foster teamwork, handle pressure, and provide feedback.
Experience participating on cross functional teams.
Business Admin for CAPA System administrative activities:
Establish and manage user accounts and security access
Ensures continuous and timely workflow processing of quality records
Ensures data integrity and retention of quality records
Manages reporting mechanisms to enable review and action
Performs required trainings as needed
Must Have: Minimum Qualifications
Bachelors degree required
Minimum of 2 years of relevant experience, or advanced degree with 0 years of experience
Nice to Have
Experience with CAPA Ownership
Experience in an FDA regulated environment is strongly recommended.
Knowledge level of quality system requirements in the US, Canada, EU and other countries.
Knowledge level of Quality and Regulatory requirements which include Risk Management, Complaints, Investigations, CAPAs, and Quality.
Notifications. (ISO 13485 2016, 21 CF 820, and ISO 14971).
Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.
We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let's work together to address universal healthcare needs and improve patients' lives. Help us shape the future.
Physical Job Requirements
The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America)