Summary:
Monitors, coordinates and perform quality systems processes in order to sustain and improve quality systems, helping to increase quality of products and processes, consistent with established medical device industry standards and corporate objectives.
- General Responsibilities _
- Supports to implement and maintain systems to ensure the measurement of progress towards key quality goals and objectives.
- Maintains and develops the quality system to fulfill requirements (e.g. ISO 9001 and 13485, 21 CFR part 820).
- Creates and revises procedures and work instructions as needed to maintain ISO 13485 and ISO9001 compliance.
- Maintains alliance with local and corporate Quality and Regulatory Affairs to ensure participation in and understanding of associated initiatives as harmonization of quality systems.
- Management Reviews support as properly documented to reflect the status of the Quality System effectiveness, coordinate and follow up on resulting corrective actions and improvement plans/actions.
- Internal Audit Coordination assuring compliance with ISO 13485, ISO9001 standards and FDA regulation, ensure compliance in a timely manner
- Coordinate activities in preparation of External Audits (Customer, BSI, Corporate etc).
- Complete customer surveys, inquiries.
- Support on Customer Quality Agreements coordination.
- Participle in Key Quality Business Metrics and Department Me
- Support on Customer Complaints and CAPAs activities.
- Support on Quality Agreements coordination.
- Perform Trackwise activities and track and monitor that actions are closed on time.
- Participle in PPI activities related to its PMD.
- Other duties may be assigned, as required.
- Education:_
- _ BA/BS in _Engineering or Science or equivalent training and /or experience, with focus on Industrial Engineering and/or Quality Engineering
- Internal Auditor Certification on ISO 9001:2015, ISO 13485:2016
Experience
- 2 years in the Quality System area, in an ISO 9001 and/or ISO 13485. Medical-device manufacturing company. (Desirable).
- Strong computer skills including data-based programs such as excel.
- Experience with problem-solving techniques such as PPI, 8-Steps, DMAIC
- Strong leadership, communication, and personnel management skills that inspire and motivate a team.
- Must have had experience with formal goal and objectives setting.
- Must have experience working with and managing multiple projects and teams simultaneously.
**Languages**:
Intermediate English Level (Reading, Intermediate conversation, able to do fluid presentations).
**Skills**:
- Ability to write technical reports.
- Strong ability to manage projects and work requirements.
- Ability to read, analyze, and interpret common quality standards, scientific and technical journals, financial reports, and safety documents.
- Ability to respond to common inquiries from customers.
- Ability to effectively present information to groups of employees, other managers and top executives.
- Ability to define problems, collect data, establish facts, and draw valid conclusions.
