Quality Engineer

TOMZ - Berlin, CT

Full-time - Mid Level

Berlin, CT

About the position

TOMZ Corporation, a leader in manufacturing of devices and components for major medical device companies, is looking for a highly motivated Quality Engineer to join our organization! Founded in 1988, TOMZ continues to be a family owned and operated organization which offers competitive compensation and excellent benefits. Those include 401k, health/dental, vision, and paid time off. TOMZ maintains a modern, clean, and safe facility with state-of-the-art equipment and dedication to continuous process improvement. TOMZ is registered with the FDA as a Class 2 and Class 3 Medical Device Manufacturer and is certified to ISO 13485. This position will be responsible for the activities associated with Quality Design & Development (QD&D) Control and Assurance during Product Development Process (PDP) activities as well as continuation design & development support for sustaining manufacturing and product distribution.

Responsibilities

• Must be knowledgeable of, and adhere to, the TOMZ Quality Management System.
• Author and execute Quality Plans for Quality Product Design and Development projects.
• Initiate and/or consult in the development and/or update of Risk Management documentation in cooperation with cross-functional engineering teams per project requirements.
• Establish severity and risk-based Process Master Validation Plan strategies with appropriate V&V rationales.
• Support operational and process qualifications for customer manufacturing processes in cooperation with cross-functional engineering teams per project requirements.
• Drive Test Method development (w/ Operational and Business considerations) and execution of Test Method Validations to measure effectiveness.
• Provide direction in implementing Incoming, In-Process, and Final Product Inspection plans.
• Develop and justify appropriate sampling plans with characterization of test/inspection methods.
• Champion First Article Inspections and Component Qualifications.
• Represent Quality Engineering in design reviews throughout the process development process.
• Support initial qualification audit activities (Customer and Regulatory Agencies).
• Assist in qualification activities associated with supplier/vendor design characterization requirements for projects, to include audits and assessments.
• Support and enforce Quality Best Practices and GDP/GMP continuous improvement efforts.
• Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
• Ensure compliance of all site personnel to site-level QMS and training requirements.
• May support the development of Quality Agreements for external customers.
• Other duties and responsibilities as assigned.

Requirements

• Minimum 4-Year degree or equivalent of directly transferrable industry work experience (Engineering or Quality discipline preferred).
• Minimum of 4+ years of experience in a regulated manufacturing environment.

Nice-to-haves

• Advanced Post-Secondary Education/Training/Certification coursework
• Quality certification(s) (e.g. ASQ CQE, QCI, etc.).
• Class I, II, and/or III Medical Device manufacturing experience.
• Regulated manufacturing industry experience (e.g. Aerospace, Defense, Pharmaceutical, etc.).
• Knowledge and experience with external standards: ISO 900/9001, ISO 13485, and 21CFR 820, EU MDR, especially pertaining to product development, design controls, good manufacturing practices, supplier qualification, auditing, quality control (GD&T, Nonconforming Materials, MRB), Corrective and Preventive Actions, and customer complaints).
• Experience in effectively supporting audits by customers and external regulatory agencies.
• Strong verbal and written English language communication skills.
• Successfully meet TOMZ-specific positional/functional on-the-job training requirements.
• Competency with Microsoft Office (i.e. Outlook, Word, Excel, and PowerPoint).
• "Hands-on" self-starter with ability to work both independently and as part of a team.
• Ability to work with a variety of functional areas, including R&D, Manufacturing, and QA.

Benefits

• 401k
• health/dental
• vision
• paid time off