Senior Supplier Quality Engineer (Exton, PA)

Senior Supplier Quality Engineer

Exton, PA

Hybrid - In office 2 days a week (subject to change)

The Sr. Supplier Quality Engineer will support the Business Unit regarding engineering activities for the ongoing and evolving stability and predictability of the supply chain. Interfacing with internal and external stakeholders to appropriately qualify and maintain suppliers for all product lines. Expected tools to meet these requirements include supplier and component qualifications, data analysis, statistical process control (SPC), CAPA and KPI’s, review and trending. Supplier Quality is responsible for supplier product-related root cause analysis, process mapping and impact assessments for change control. Supplier Quality will lead in CMO/Supplier audits and associated downstream actions to meet dsm-firmenich expectations. As a senior member in the supplier quality engineering team, the senior supplier quality engineer is expected to provide subject matter expertise in supplier management, understand and evolve internal systems to efficiently meet requirements, interface with vendors of all sizes, and provide leadership to the supplier quality engineering team.

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

Key Responsibilities:

• Expected to serve as primary quality contact with vendors of all sizes and complexities.
• Own and manage the supplier qualification process and Approved Supplier List.
• Develop, document, and implement QA Procedures.
• Analyze internal systems for improvement and drive the improvement efforts.
• Perform external audits of CMOs/suppliers to appropriate criteria, report findings, and develop and track actions as required.
• Establish and negotiate Quality Agreements with required supply chain partners.
• Analyze non-conforming materials and returned goods and recommend disposition and corrective actions
• Prepare, review, and approve technical reports and provide recommendations based on data rationale.
• Develop, lead, and review root causes for non-conformances and deviations.
• Review documentation for completeness and accuracy.
• Complete other tasks and projects as assigned by the Supplier Quality Engineering Manager.
• Lead focused, multidisciplinary teams with clear objectives.
• Serve as leader, teacher, and mentor to other supplier quality team members.
• Work occasionally in a clean room setting following protective procedural requirements and comply with all safety requirements, including posted placards, SOPs and the Safety Manual.
• Adhere to Quality System procedures, ISO13485, 21CFR part 820 and current regulatory standards.

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.

You Bring:

• Bachelor’s degree in Engineering or Life Sciences.
• 3-5 years Quality Engineering or Supplier Management within a regulated industry: Medical Device, Pharmaceutical, Biotech.
• Experience with ISO 9001, or ISO 13485, or 21 CFR820 desired.
• Ability to travel ~25% both domestic and international.
• Computer literacy (Microsoft Office, Project, Document Management Systems).
• Lead auditor certification a plus.
• Six Sigma, ASQ QE or CQA Certification a plus.
• Excellent organizational, leadership, 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.

•  Statistical techniques and software (i.e. – Minitab).

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 applicant's 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.

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.