Detalle de la Oferta

Descripción de la Oferta

The Quality Systems Specialist is responsible for supporting the establishment of a compliant/ effective Quality Management System (QMS), developing /revising QMS process documents, such as SOPs and quality manuals, ensuring their accuracy/currency, as well as other QMS related responsibilities.

Your role:

- Participates in the effective deployment and continuous improvement of QMS processes in the assigned area/areas such as document control, training, and audits, by providing technical expertise and ensuring compliance with regulatory standards.
- Supports data collection on QMS performance metrics, such as non-conformances, critical findings, and training completion rates, to support management in decision-making.
- Contributes to continuous improvement initiatives by identifying opportunities for enhancing efficiency and compliance within existing QMS processes and providing support in implementing improvements.
- Participates in the planning and organization of internal audits by preparing necessary documentation, assisting audit teams during audits, and ensuring follow-up actions are completed.
- Ensures proper maintenance, organization, and archiving quality records in accordance with QMS procedures, regulatory requirements, and company policies to maintain audit readiness.
- Collaborates with cross-functional teams and stakeholders to ensure effective communication and understanding of QMS processes and provide basic guidance on compliance-related inquiries.
- Participates in problem-solving sessions by providing data and insights related to quality processes, supporting the identification of root causes, and recommending potential corrective actions.
- Works under general supervision and established processes, utilizing independent judgment to navigate and adhere to operational policies, ensuring compliance and optimal performance.
- Engages in risk management activities, identifying potential risks to regulatory compliance, quality and QMS integrity, and proposing mitigation strategies to minimize impact.
- Participate in training sessions to stay updated on quality standards and QMS procedures, actively engaging in learning opportunities to enhance understanding of industry regulations and best practices.
- Develop professional expertise and apply comprehensive knowledge of company products and services to effectively address challenges and opportunities.

You're the right fit if:

- You have a minimum of 2+ years of experience in FDA regulated medical device manufacturing quality environments, with a focus on Quality Management Systems compliance/effectiveness, developing/revising QMS process documents, Audit support, Corrective actions (CAPA), and root cause analysis.
- You have a strong Understanding of global medical device regulations, requirements, and standards such as 21 CFR 820, ISO13485, EUMDR, and ISO9001.
- You're able to collect, analyze and report on QMS performance data/metrics and track non-conformance reports, contributing to continuous improvement activities.
- You have a minimum of a Bachelor's Degree in Engineering, Sciences, similar disciplines or equivalent.
- You have advanced level communication in English (verbal/written).
- You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position .

How we work together

We believe that we are better together than a part. For our office-based teams, this means working in-person at least 3 days per week. Onsite roles require full-time presence in the company's facilities. Field roles are most effectively done outside of the company's main facilities, generally at the customers' or suppliers' locations. This is an office role.

About Philips

We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody, everywhere, has access to the quality of healthcare