Quality Specialist

Matlen Silver; Kalamazoo (MI); Sur place; USD 55 000 - 58 000; Plein temps

Résumé du poste

Matlen Silver is seeking a Quality Specialist in Kalamazoo, MI to support the Instruments PEC PMO portfolio. The role focuses on structured data gathering, validation, and integration for regulatory compliance across global teams and suppliers.

Responsibilities include data cleansing, ECN management within QMS, and collaboration with Engineering, Regulatory, and Supply Chain to ensure audit-ready documentation and timely PEC submissions.

Qualifications

• Bachelor’s degree in engineering or related field.
• Ability to gather, analyze, and validate data from multiple sources.
• Strong attention to detail and data interpretation skills.
• Excellent communication and collaboration with global teams.
• Strong organizational and project management capabilities.

Responsabilités

• Lead data retrieval and collection across internal and external sources to support PEC regulatory requirements (e.g., REACH, RoHS, PFAS, PPWR).
• Compile, cleanse, and validate datasets for regulatory submissions and internal reporting.
• Partner cross-functionally to obtain material, component, and product-level compliance data.
• Create and manage ECNs within the QMS to implement PEC updates and ensure audit readiness.
• Translate regulatory requirements into data needs and evidence for compliance initiatives.
• Support supplier engagement to obtain declarations and certifications.
• Perform data analysis and identify gaps; drive resolution with stakeholders.
• Maintain project-tracking tools and dashboards for data collection progress and risks.
• Contribute to process improvements by standardizing data collection methods and templates.
• May act as Change Owner coordinating implementation plans and timelines.

Connaissances

Data retrieval

Data analysis

Attention to detail

Cross-functional collaboration

Project management

Regulatory compliance knowledge

Communication

Formation

Bachelor’s degree in engineering or related field

Outils

Windchill

onePLM

Description du poste

Quality Specialist

Duration: 18 months + Potential Extension

Location: Kalamazoo, MI, 49002

Required Pay Scale: $40-42/hr

Due to client requirements this role is only open to USC or GC and local candidates

Due to client requirements this role is only on W2

Job Summary

We are seeking to hire a Specialist, Change Control & Data Retrieval/Collection to support the Instruments Product Environmental Compliance (PEC) PMO portfolio.

• Collaborative partners: Individuals who build strong cross-functional relationships to gather, validate, and align data across global teams, suppliers, and systems.
• Detail-oriented problem solvers: Professionals who can navigate complex datasets, trace information across multiple systems, and ensure accuracy and completeness for regulatory compliance.
• Goal-oriented achievers: Individuals who thrive in fast-paced environments and are focused on delivering compliant, high-quality outputs aligned to evolving PEC requirements.
• Continuous improvement drivers: People who proactively identify gaps in data availability, quality, and processes, and work to enhance data collection and reporting mechanisms.

Roles & Responsibilities

• As the Specialist, Change Control & Data Retrieval/Collection, you will play a critical role in enabling PEC initiatives through structured data gathering, validation, and integration activities. You will: Lead data retrieval and collection efforts across internal systems (e.g., PLM, ERP, QMS) and external sources (e.g., suppliers) to support PEC regulatory requirements (e.g., REACH, RoHS, PFAS, PPWR).
• Compile, cleanse, and validate complex datasets to ensure accuracy, traceability, and readiness for regulatory submissions and internal reporting.
• Partner cross-functionally (Engineering, Supply Chain, Regulatory, Quality, and external suppliers) to obtain required material, component, and product-level compliance data.
• Create and manage Enterprise Change Notices (ECNs) within the Quality Management System to implement updates tied to PEC findings, ensuring all documentation and data inputs are compliant and audit ready.
• Translate regulatory requirements into data needs, identifying required attributes, documentation, and evidence to support compliance initiatives.
• Support supplier engagement and outreach to request, track, and follow up on material declarations, certifications, and compliance documentation.
• Perform data analysis and gap assessments, highlighting missing or inconsistent information and driving resolution with stakeholders.
• Maintain and update project tracking tools and dashboards, ensuring visibility to data collection progress, risks, and completion status across PEC programs.
• Contribute to process improvements by standardizing data collection methods, templates, and workflows to enhance efficiency and scalability of PEC efforts.
• May act as Change Owner as needed, coordinating implementation plans and ensuring execution aligns with regulatory timelines.

Required Skills

• Bachelor’s degree in engineering or related field
• Strong attention to detail with the ability to manage and interpret complex datasets
• Demonstrated ability to gather, analyze, and validate data from multiple sources
• Excellent communication and collaboration skills across diverse, global teams
• Strong organizational and project management capabilities

Preferred Skills

• Experience in change control or change management within a regulated industry
• Experience in the medical device industry
• Familiarity with Product Environmental Compliance (PEC) regulations (e.g., REACH, RoHS, PFAS)
• Experience with PLM tools (Windchill/onePLM) or similar systems
• Experience working with supplier data collection and compliance documentation