Sr Quality Applications Spec at Medtronic in Juncos, Puerto Rico

Job Description:

Careers that Change Lives
A Day in the Life
Responsibilities may include the following and other duties may be assigned.

• Conducts a compliant validation process for quality information technology systems which requires formal validation documentation (including standard operating procedures) under appropriate federal regulations.
• Coordinates activities with clients, programmers/developers and operating personnel, domestic and, as appropriate, global.
• Identifies current and anticipated requirements for compliant computerized operations and suggests methods for the identification, implementation and maintenance of the procedures, actions and documentation necessary to assure compliance according to the appropriate federal and international regulations which govern the user's applications.
• Reports on the status of validation activities to fulfill regulatory requirements.
• Keeps abreast of changing federal and international regulatory requirements, government audit policies, and the availability of current techniques.
• Performs system administration and configuration of quality information technology systems.
• Designs or specifies inspection and testing mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to assess the cost of and determine the responsibility for, products or materials that do not meet required standards and specifications.
• Review and analyze quality trends. Considering the quality trends provides directions in terms of setting work priorities for process enhancement.
• Provides leadership to effective in-depth investigations and to cross-functional, multilevel technical teams to assure causes of non-conformance are identified and understood, and that sound corrective/ preventive actions are implemented.
• Evaluates the implemented corrective and preventive actions against trends and quality issues to assess effectiveness of it.
• Leads investigation of customer complaints in alignment with the manufacturing engineers, and process supervisors, facilitates the implementation process.
• Analyzes data based on trends, recommends actions for process, equipment and system improvement.
• Writes procedures, protocols and any other documentation needed for the enhancement of systems.
• Analyzes problems regarding inspection procedures, reaches decisions and recommends possible solutions and improvements to implement corrective and preventive actions.
• Initiates, reports, and recommends special studies and qualification of new products or processes to evaluate quality and reliability.
• Reviews and approves qualification / validation reports, ECO's, process changes, quality records or manufacturing documentation.
• ' mplements quality system improvements.
• Conducts and assists in regulatory inspections, such as (TÜV, FDA, others), as well as internal audits.
• Manage supplier related events with suppliers including but not limited to supplier communication, supplier investigation and supplier CAPA activities.

Must Have: Minimum Requirements

• Bachelors degree required
• Minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience

Nice to Have

• Bachelor degree (Engineering)
• Experience managing quality events including risk assessment, investigation, corrective actions, implementation and CAPA records management.
• SAP Quality Module knowledge
• Factory Works MES system knowledge
• Nonconforming Product Management knowledge

About Medtronic
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)

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