Quality Applications Manager - Quality Data Analytics
Role details
Job location
Tech stack
Job description
As the Quality Applications Manager - Quality Data Analytics , your key responsibilities will include the following (and other duties may be assigned):
- Lead the strategy, prioritization, and execution of Quality data initiatives that improve data quality, access, automation, self-service analytics, visualization, and insight generation across the Quality organization.
- Direct and oversee a dynamic team of advanced developers and analysts that plan and execute actions, develop tools and reports, and provide insights on Quality data.
- Establish and maintain effective working relationships with key stakeholders across the Enterprise with a focus on Quality and IT.
- Manage a growing portfolio of data and analytics assets and information technology infrastructure to ensure continuity and continuous improvement.
- Establish and maintain management mechanisms to drive team accountability, execution, effective communication, and cohesion.
- Oversee initiatives that drive continuous improvement with a focus on efficiency and automation
- Manage vendor relationships and contracts.
- Represent and support the Quality Data Analytics function in audits and regulatory inquiries.
- Guide their team through the regular use of a compliant validation process for quality information technology systems and reports, which requires formal validation documentation (including standard operating procedures) to meet appropriate regulations.
- Coordinate activities with clients, programmers/developers, and operating personnel, domestic and, as appropriate, global.
- Identify current and anticipated requirements for compliant computerized operations and suggest 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 that govern the user's applications.
- Report on the status of validation activities to fulfill regulatory requirements.
- Keep abreast of changing federal and international regulatory requirements, government audit policies, and the availability of current techniques.
- Support the design, administration, and configuration of quality information technology systems., To be considered for this role, please ensure the minimum requirements and your permanent address are evident on your resume.
Requirements
- Bachelor's degree required with a minimum of 5 years of relevant experience in complaint handling, regulatory submissions/inquiries and data analytics: OR an advanced degree with a minimum of 3 years of relevant experience in complaint handling, regulatory submissions/inquiries and data analytics., * Quality systems knowledge for medical device or similar regulated industry (i.e. CAPA, Audit, Configuration Assurance, Training, FCA/PHO, Complaint Handling, etc.).
- Understanding of IT systems, applications, data flow, and databases, as well as integration methodologies and best practices. Knowledge in core systems such as Databricks, Business Objects, Power BI, and Power Apps.
- Experience in automation (inclusive of hyper automation) technologies, tools, or processes.
- Analytical mindset: Problem-solving abilities to identify risks, evaluate options, and make informed decisions; experience with advanced analytical tools and methods.
- Continuous improvement mindset: Lean/Six sigma, CMMI certification or similar.
- Program Management: focus on high-quality, high-ethics execution and removal of roadblocks; ability to manage multiple initiatives simultaneously.
- Excellent communicator: active listening, verbal, and written; ability to collaborate effectively with and influence cross-functional teams and stakeholders.
- People Leadership: create effective interpersonal relationships; motivate, engage, and grow talent.
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.
Benefits & conditions
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.
Salary ranges for U.S (excl. PR) locations (USD):$120,000.00 - $180,000.00
This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).
The base salary range is applicable across the United States, excluding Puerto Rico and specific locations in California. The offered rate complies with federal and local regulations and may vary based on factors such as experience, certification/education, market conditions, and location. Compensation and benefits information pertains solely to candidates hired within the United States (local market compensation and benefits will apply for others).
The following benefits and additional compensation are available to those regular employees who work 20+ hours per week: Health, Dental and vision insurance, Health Savings Account, Healthcare Flexible Spending Account, Life insurance, Long-term disability leave, Dependent daycare spending account, Tuition assistance/reimbursement, and Simple Steps (global well-being program).
The following benefits and additional compensation are available to all regular employees: Incentive plans, 401(k) plan plus employer contribution and match, Short-term disability, Paid time off, Paid holidays, Employee Stock Purchase Plan, Employee Assistance Program, Non-qualified Retirement Plan Supplement (subject to IRS earning minimums), and Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums).
Regular employees are those who are not temporary, such as interns. Temporary employees are eligible for paid sick time, as required under applicable state law, and the Employee Stock Purchase Plan. Please note some of the above benefits may not apply to workers in Puerto Rico.
Further details are available at the link below:
Medtronic benefits and compensation plans (https://www3.benefitsolver.com/benefits/BenefitSolverView?page_name=signon&co_num=30601&co_affid=medtronic)