Quality Engineer III

Viant Medical•Chicopee, MA

25d

About The Position

We're a company of agile, customer-oriented individuals with a shared commitment to integrity, servant leadership, and teamwork. Our associates take pride and ownership in their work, and innovate to provide the highest quality, life-enhancing medical technology in the world. Together, We're in It for Life. The primary purpose of Quality Engineer III is to provide support for Operations to ensure that the Quality System requirements are adhered to for medical device manufacturing/operations in accordance with applicable Regulatory and Standards requirements for compliance.

Requirements

Ability to read and write in English.
Self-motivated with strong ability to adapt to change.
Ability to work cross-functionally and as part of a project team.
Ability to read and interpret technical drawings.
Proficiency in statistical tools (e.g., Gage R&R, Capability Analysis, ANOVA); Minitab experience is a plus.
Experience in ISO 13485 industry.
Ability to conduct root cause investigations using techniques such as FMEA, Fishbone, 5 Why, and 8D.
Knowledge of Process Validation (IQ, OQ, PQ, TMV).(Must)
Detail-oriented with strong organizational skills.
Experience in audit processes (internal or external audits).
BS degree in a related discipline or High School Diploma with 10+ years of relevant experience.
5-8 years of relevant experience.
Experience in the medical device industry

Nice To Haves

Certified ISO Auditor training.
Experience with Quality Management System (IQMS).
Advanced proficiency with Microsoft programs.
Experience applying statistical tools and using Minitab.
Familiarity with process validation and quality methodologies.

Responsibilities

Adheres to Viant Core Values and all safety and quality requirements including, but not limited to: Quality Management Systems (QMS), Environmental Management Systems (EMS), U.S. Food and Drug Administration (FDA) regulations, Company policies and operating procedures, and other regulatory requirements.
Auditing experience with regulatory and agency inspections, audits, investigations, and inquiries regarding the control and assessment of product design and manufacturing quality. Front room experience desired.
Monitors manufacturing of assigned products, assuring compliance with DMR and quality system requirements and assuring complete and correct Device History Records are maintained.
Leads site process and product improvement initiatives.
Participates in the development, completion, and maintenance of risk analyses.
Leads the generation and completion of protocols and reports for product, process, and test method validations.
Collaborates with Manufacturing Engineers to review processes for new and existing products and supports the coordinate of process validations and capability studies.
Supports the development various inspection techniques and procedures to ensure product integrity to design specifications. Responsible for the writing, implementation, and training of Incoming, In-Process, Manufacturing instructions, and Final Inspection procedures.
Supports the disposition of non-conforming materials meet all necessary regulatory requirements and assure adequacy of corrective actions to prevent re-occurrence.
Conducts root cause complaint investigations and remediation recommendations as needed.
Key team member in CAPA activities, including analysis of data and trends in complaints, supplier quality, nonconforming material, training effectiveness, and root causes analysis.
Assists with product transfers.