Quality System Specialist, Hybrid, Exton, PA (USA)

Quality System Specialist

Exton, PA (USA)

(Hybrid ) Monday-Friday (January 2025 start date)

As a Quality System Specialist , you will assure that dsm-firmenich products are of consistently high quality by managing, maintaining, continually improving, where applicable, and assisting in the operation and development of the Quality Management Systems, regulatory requirements, and execution for DSM Biomedical, Exton.

At dsm-firmenich, being a force for good is not optional. Diversity, Equity & Inclusion is a shared responsibility woven into our daily work, benefiting to our People, Customers & Communities and driving business value. Equal access to opportunities is a given, belonging is a shared feeling, authenticity is celebrated.

Responsibilities:

Lead the internal audit program by creating & maintaining the audit schedule, following up on and approving internal audit plans / reports, and completing any post- internal audit activities.

Support external audits by maintaining the audit calendar, managing data sharing applications, scheduling the meeting requests / audit placeholders in addition to coordinating day of and pre-audit requests.

Review, approve and participate in root cause determinations & CAPA implementation for Corrective and Preventive actions.

Support the customer complaints process, including entering complaint information into the related system and completing Level 1 investigations (DHR reviews) on complaints.

Respond to customer requests by completing surveys, collecting, and providing data, records, documents, and other requested information.

Support Management Review by capturing meeting minutes, attendance, and any records required as an output of the meeting.

Manage a list of applicable external standards, monitor changes to these documents and issue and track the gap analysis tasks of related Subject Matter Experts.

We Bring:

A competitive compensation package, with comprehensive health and welfare benefits.

A place to grow and develop.

A company that is purpose-led and performance-driven in a corporate culture that values people and planet.

The opportunity to work on growing brands and build on a strong foundation.

The chance to make improvements and make an impact on the business.

This position embraces a Hybrid Working model, offering the flexibility of both office and remote work. Initially (3 months) youll be on-site for 5 days a week, transitioning gradually to 50% in your home office once you’re fully acclimated.

You Bring:

BS Degree in Quality, Science, or Engineering or equivalent undergraduate experience.

0 – 3 years Quality Systems, Complaint Management, Quality Assurance, or related discipline at an FDA-Regulated Medical Device, Pharmaceutical, Biotech, or other regulated industry.

Auditing readiness experience.

Excellent organizational, decision-making, and analytical skills.

Excellent written and verbal communication skills, including writing, editing, and proofing skills.

Well-developed inter-personal and teamwork skills to communicate and resolve product quality issues with R&D, Production, Engineering, and other departments.

Demonstrated ability to multi-task resulting in positive outcome for each task assigned or self-generated.

Experience with or ISO 13485 and 21 CFR 820 desired.

Proficient in MS Office software including Word, Excel, and Outlook.

Arena, Blue Mountain, and SAP a plus.

dsm-firmenich is fully dedicated to inclusion because when people feel engaged and empowered, their creativity and innovation drives unprecedented progress. We aim to build a workplace where opportunity really is equal, so everyone can thrive. We do not discriminate: there’s a place for everyone at dsm-firmenich.

As a committed equal opportunity employer, we ensure our recruitment practices are inclusive and fair. We encourage the recruitment of a diverse workforce, representative of the communities in which we work, by using inclusive language, diverse interview panels, diversified sourcing strategies. Selection is based on qualifications, competency, experience, performance history and fit with the team to advance fair and equitable opportunity.

Employment decisions are based upon job-related reasons regardless of an applicants race, color, ethnicity, national origin, religion, gender, gender identity or expression, sexual orientation, age, disability, backgrounds, genetic information, protected veteran status, or any other status protected by law.

We are committed to providing reasonable support for disabled applicants in our recruiting process. Should you need assistance, and are comfortable to share this, please let us know.

About dsm-firmenich

As innovators in nutrition, health, and beauty, dsm-firmenich reinvents, manufactures, and combines vital nutrients, flavors, and fragrances for the world’s growing population to thrive. With our comprehensive range of solutions, with natural and renewable ingredients and renowned science and technology capabilities, we work to create what is essential for life, desirable for consumers, and more sustainable for the planet. dsm-firmenich is a Swiss-Dutch company, listed on the Euronext Amsterdam, with operations in almost 60 countries and revenues of more than €12 billion. With a diverse, worldwide team of nearly 30,000 employees, we bring progress to life™ every day, everywhere, for billions of people. www.dsm-firmenich.com

Please note this is a direct search led by dsm-firmenich. We only accept applications from candidates, not from agencies nor subject to agency’s fees, percentages or similar.