Quality Systems Specialist

Medtronic; Tempe (AZ); On-site; USD 72,000 - 110,000; Full time

Job summary

A leading company in healthcare technology is seeking a Quality Systems Specialist in Tempe, Arizona. The role involves ensuring compliance with CAPA processes and FDA regulations, providing guidance to teams, and supporting audits. Candidates should have a relevant degree and experience in quality systems.

Benefits

Health Insurance

Dental Insurance

Vision Insurance

401(k) plan with employer contribution

Tuition assistance

Paid time off

Employee Stock Purchase Plan

Qualifications

• 2+ years experience in Quality or regulated industry.
• Experience with non-conformances and CAPA processes.

Responsibilities

• Ensure compliance with CAPA processes and medical device regulations.
• Provide oversight for quality programs and prepare necessary documentation.

Skills

Analytical

Critical Thinking

Decision-Making

Education

Bachelor's degree

Advanced degree

Tools

TrackWise Digital Quality Management Software

Job description

Quality Systems Specialist page is loaded

Quality Systems Specialist

Bewerben remote type Generator locations Tempe, Arizona, United States of America time type Full time posted on Vor 2 Tagen ausgeschrieben time left to apply Enddatum: 22. Mai 2025 (Noch 5 Tage Zeit für Bewerbung) job requisition id R30564 We anticipate the application window for this opening will close on - 22 May 2025

Bei Medtronic kannst Du eine Karriere für Dein Leben starten. Und Dich für ein gerechtes und innovatives Gesundheitswesen einsetzen, das für alle zugänglich ist. Du wirst zielstrebig Barrieren abbauen, die Innovationen in einer stärker vernetzten und solidarischen Welt im Wege stehen.

Ein Tag im Leben

Act boldly. Compete to win. Move with speed and decisiveness. Foster belonging. Deliver results…the right way. That’s the Medtronic Mindset — our cultural norms. Our brand is rooted in action, not just words. The Medtronic Mindset defines the expectations of our culture. Every person here plays a role in bringing it to life. We recognize your extraordinary potential to ensure future generations live better, healthier lives.

In this exciting role as a Quality Systems Specialist – CAPA Specialist supporting the Tempe Campus - you will have responsibility for compliance to the Corrective and Preventive Action (CAPA) processes and Medical Device regulations and requirements, serve as a CAPA subject matter expert; provide guidance to CAPA owners and CAPA Board members to develop CAPA activities and conduct assessment of CAPA documentation.

The Quality System CAPA Specialist will ensure compliance with Medtronic policies, FDA regulations, ISO 13485, and other requirements by rigorously assessing CAPA activities and documentation. They will participate in CAPA Board activities, provide guidance and mentorship on CAPA processes and tools, and report on CAPA metrics. Additionally, they will support the development and implementation of CAPA procedures, software, and training, and assist in internal and external audits and inspections.

Responsibilities may include the following and other duties may be assigned:

1. Provide oversight for the development and maintenance of quality programs, systems, processes and procedures that ensure compliance with policies and that the performance and quality of services conform to established internal and external standards and guidelines.

2. Provide expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and internal regulations to assure compliance.

3. Work directly with operating entities to provide process analyses oversight on a continuing basis to enforce requirements and meet regulations.

4. Prepare reports and/or necessary documentation (e.g., Corrective and Preventative Actions) and provide to applicable stakeholders, both internal and external.

5. Coordinate legal requests in support of government investigations or litigations.

6. Ensure the quality assurance programs and policies are maintained and modified regularly.

7. Facilitate uniform standards worldwide and enables best practice sharing, thereby fostering the achievement of company's mission globally.

8. Location: Onsite - Tempe, AZ.

Must Have: Minimum Requirements

To be considered for this role, please ensure the minimum requirements are evident in your applicant profile.

• Bachelor's degree with 2+ years of work experience in Quality or regulated industry OR Advanced degree with 0 years of work experience in Quality or regulated industry

Nice to Have

• Experience working with non-conformances, corrective and preventive actions.

• Experience conducting effective root cause investigation, corrective and preventive action planning and execution and verification of effectiveness techniques.

• Knowledge of effective root cause investigation, corrective and preventive action planning and execution and verification of effectiveness techniques.

• Support CAPA process and several individual records for a specific set of CAPAs that will have high visibility and require increased oversight.

• Experience in medical device, pharmaceutical and/or a comparable regulated environment.

• Experience working with non-conformances, corrective and preventive actions.

• Strong analytical, process improvement, critical thinking and decision-making skills.

• Ability to educate people in the CAPA program.

• CAPA documentation systems experience (e.g., TrackWise Digital Quality Management Software).

• Lean Six Sigma certification (Yellow belt, Green belt, or Black belt).

• Influence management skills; ability to work constructively across all functions of the organization as well as external customers.

• Project management skills.

• Experience reviewing technical documentation.

• Strong written and verbal communication skills.

• Understanding of FDA regulations (21 CFR 820, 210/211 as applicable and Part 11), ISO 13485, and Medtronic quality requirements.

Physische Jobanforderungen

Die obigen Angaben sollen die allgemeine Art und das Niveau der Arbeit der Mitarbeitern in einer solchen Position beschreiben, es handelt sich aber dabei nicht um eine vollständige Liste aller für diese Position erforderlichen Aufgaben und Fähigkeiten.

Die im Abschnitt „Aufgaben“ dieser Stellenbeschreibung beschriebenen körperlichen Anforderungen sind repräsentativ für die Anforderungen, die ein Mitarbeiter erfüllen muss, um die wesentlichen Funktionen dieser Stelle erfolgreich auszuführen. Es müssen zumutbare Hilfsmaßnahmen unternommen werden, um Personen mit Behinderung die Ausübung der wesentlichen Funktionen zu ermöglichen. Für Bürotätigkeiten: Für die Ausübung solcher Tätigkeiten ist es erforderlich, dass der Mitarbeiter regelmäßig selbständig mobil ist. Der Mitarbeiter muss zudem mit einem Computer umgehen können sowie mit internen und externen Kollegen kommunizieren. Wenden Sie sich an Ihren Vorgesetzten oder an die örtliche Personalabteilung, um sich über eventuelle für die jeweilige Stelle spezifische Arbeitsbedingungen und körperliche Anforderungen zu informieren.

Leistungen und Vergütung

Medtronic bietet ein wettbewerbsfähiges Gehalt und ein flexibles Leistungspaket
Das Engagement für unsere Mitarbeiter ist der Kern unserer Werte. Wir schätzen die Beiträge jedes einzelnen. Sie tragen damit zu unserem Erfolg bei.Wir bieten für jede Karriere- und Lebensphase umfassende Leistungen, Ressourcen und wettbewerbsfähige Vergütungspläne.

Salary ranges for U.S (excl. PR) locations (USD):$72,800.00 - $109,200.00This 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 Leistungs- und Vergütungspläne

Über Medtronic

Wir sind weltweit führend im Bereich Gesundheitstechnologie und suchen und finden Lösungen für die drängendsten medizinischen Probleme der Menschheit.
Unsere Mission, Schmerzen zu lindern, die Gesundheit von Patienten wiederherzustellen und ihr Leben zu verlängern, eint ein weltweites Team von mehr als 95.000 engagierten Mitarbeitern.

Im Herzen sind wir Ingenieure, die ehrgeizige Ideen umsetzen, um echte Lösungen für echte Menschen zu entwickeln. Ob im Labor, in der Fabrikhalle oder im Konferenzraum– jede*r von uns experimentiert, schafft, baut, verbessert und löst Probleme. Mit unseren Kompetenzen, den unterschiedlichen Perspektiven und unserem Pioniergeist sind wir dazu berufen, Außergewöhnliches zu schaffen.

• Erfahren Sie mehr über unser Engagement für Diversität und Inklusion unter

Einer unserer Grundsätze ist gleiche Beschäftigungschancen für alle, unabhängig von Alter, Hautfarbe, nationaler Herkunft, Staatsangehörigkeit, Behinderung, Rasse, Religion, Glauben, Geschlecht, sexueller Orientierung, Geschlechtsidentität und/oder -ausdruck, Erbinformationen, Familienstand, Status in Bezug auf öffentliche Unterstützung, Veteranenstatus oder anderer durch staatliche, regionale oder lokale Gesetze unter Schutz gestellten Eigenschaften. Darüber hinaus trifft Medtronic angemessene Vorkehrungen für qualifizierte Personen mit Behinderungen.

Medtronic veröffentlicht die meisten Stellen 3 bis 7 Tage lang auf der Karriereseite.