Assoc Quality Application Spec- Temp Assignment

Medtronic • Villalba, PR

18d

About The Position

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world. 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. Collaborates with engineering and manufacturing functions to ensure quality standards are in place. Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements. Performs investigation non-conformance events, CAPA (corrective and preventive actions) and cost down activities. Verifies the implementation and effectiveness of non-conforming CAPA Executes job responsibilities as established in the procedures Follows the documentation procedures Non- Conformance Resolution Evaluating, Investigating & Completion of Non- Conformance Investigation (Data gathering of Quality issue) Identify Corrective/Preventive Actions Implementing Corrective/Preventive Actions Leading complaint activities with the Operating Units members Coaching Quality Technicians / MTM’s Conducts a compliant validation process which requires formal validation documentation (including standard operating procedures) under appropriate federal regulations. May provide guidance, coaching and training to other employees within job area of lower level. May manage projects, requiring delegation of work and review of others' work.

Requirements

• Requires broad theoretical job knowledge typically obtained through advanced education.
• Requires a Bachelor degree , with 0 years of experience required.
• For Baccalaureate degrees earned outside of the United States, a degree that satisfies the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A) is required.

Nice To Haves

• Knowledge of Good Manufacturing Practices
• Good oral and written communication skills (English and Spanish)
• Computer knowledge (Excel, Word, Power Point, etc.)
• Availability to work overtime and weekends when necessary
• Good problem-solving skills
• Investigation (Data gathering of Quality issue)
• Initiates, recommends, and provides solutions to the Non-Conforming Product as per procedures

Responsibilities

• 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.
• Collaborates with engineering and manufacturing functions to ensure quality standards are in place.
• Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements.
• Performs investigation non-conformance events, CAPA (corrective and preventive actions) and cost down activities.
• Verifies the implementation and effectiveness of non-conforming CAPA
• Executes job responsibilities as established in the procedures
• Follows the documentation procedures
• Non- Conformance Resolution Evaluating, Investigating & Completion of Non- Conformance Investigation (Data gathering of Quality issue)
• Identify Corrective/Preventive Actions
• Implementing Corrective/Preventive Actions
• Leading complaint activities with the Operating Units members
• Coaching Quality Technicians / MTM’s
• Conducts a compliant validation process which requires formal validation documentation (including standard operating procedures) under appropriate federal regulations.
• May provide guidance, coaching and training to other employees within job area of lower level.
• May manage projects, requiring delegation of work and review of others' work.

Benefits

• Medtronic 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 share in the success they help to create.
• We offer a wide range 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 called the Medtronic Incentive Plan (MIP).

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Number of Employees: 5,001-10,000 employees