Design Quality Engineer

Katalyst CRO; Cambridge (MA); On-site; USD 70,000 - 100,000; Full time

Job summary

A leading company in pharmaceutical manufacturing is seeking an Associate Level Design Quality Engineer. The role involves managing quality assurance processes, improving QMS documentation, and collaborating on projects related to product validation. Ideal candidates will have strong skills in supplier management and verification protocols.

Qualifications

• Experience with QMS and documentation required.
• Strong background in supplier quality management.
• Familiarity with V&V protocols essential.

Responsibilities

• Manage QMS documentation and supplier quality interactions.
• Lead training on QMS and oversee quality issue resolutions.
• Participate in change reviews and manage project-related QA activities.

Skills

QMS experience

Documentation skills

Supplier Quality Management

Verification & Validation protocols

Quality Assurance

Job description

Join to apply for the Design Quality Engineer role at Katalyst CRO.

Responsibilities include:

• Demonstrated QMS experience and documentation skills.
• Supplier Quality Management, coordination, and timely interaction.
• V&V protocols and reports.
• Extensive training on Philips' QMS, product understanding, and experience sessions.
• Activities such as closing SICRs, working with ME on FAI plans and reports, and supporting AOS/EOL projects.
• Participation in change review analysis, owning part/spec changes, defining and reviewing verification & validation protocols, and FAI development.
• Managing database records in eDMR integrated with SAP and Windchill.
• Providing first-line quality issue defense for MX40 / SH1.0, supporting repair and transfer processes.
• Generating project plans for PIE and PMO/PDLM projects, managing MLD changes, and monitoring NPI releases.

Seniority level

Associate

Employment type

Contract

Job function

Quality Assurance

Industries

Pharmaceutical Manufacturing

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