P-393737 Quality Systems Specialist
- Tp Hồ Chí Minh
- Lâu dài
- Toàn thời gian
- Coordinate audit logistics, back-end preparation, document retrieval, and follow-up on findings.
- Conduct internal audits and support external audits (ISO 13485, FDA 21 CFR Part 820, MDSAP).
- Collaborate with functional departments to plan validations and risk assessment activities.
- Report and track QMS KPIs and drive continuous improvement initiatives.
- Support layered audits, Gemba walks, and process walkthroughs.
- Assist in CAPA effectiveness checks and regulatory readiness support.
- Serve as a cross-functional compliance checkpoint for management review or inspection readiness.
- Experience: At least 3 years in a similar role; experience in the medical device or other regulated industries is a plus.
- Skills:
- Proficient in Microsoft Office (Word, Excel, Outlook, etc.).
- Proficient in English skills.
- Strong organizational, communication, and interpersonal skills.
- Understanding of document control practices and regulatory compliance.
- Detail-oriented, responsible, and able to handle confidential information with integrity.
Works independently with general supervision on larger, moderately complex projects / assignments.Organizational Impact: Sets objectives for own job area to meet the objectives of projects and assignments.
Contributes to the completion of project milestones .
May have some involvement in cross functional assignments.Innovation and Complexity: Problems and issues faced are general, and may require understanding of broader set of issues or other job areas but typically are not complex .
Makes adjustments or recommends enhancements in systems and processes to solve problems or improve effectiveness of job area.Communication and Influence: Communicates primarily and frequently with internal contacts .
External interactions are less complex or problem solving in nature.
Contacts others to share information, status, needs and issues in order to inform, gain input, and support decision-making.Leadership and Talent Management: May provide guidance and assistance to entry level professionals and / or employee in Support Career Stream.Required Knowledge and Experience: Requires practical knowledge and demonstrated competence within job area typically obtained through advanced education combined with experience.
Requires a Baccalaureate degree (or for degrees earned outside of the United States, a degree which satisfies the requirements of 8 C.F.R. § 214.2(h)( 4)(iii)(A) and minimum of 2 years of relevant experience, or advanced degree with 0 years of experience.Physical Job RequirementsThe above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.Benefits & CompensationMedtronic 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).About MedtronicWe lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people.
We are engineers at heart— putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.Learn more about our business, mission, and our commitment to diversity