Quality Engineer- New Product Development

SMC Ltd.•Devens, MA

2d•$100,000 - $130,000•Onsite

About The Position

Responsible for all areas of Quality Engineering on customer programs. Responsible for working directly with the program management, tooling and manufacturing functions to ensure adequate systems, documentation, inspection methods and tools are used throughout the organization for molding and assembling healthcare products. Understanding customer requirements and implementing appropriate controls, documentation, action plans, and tools necessary to perform quality related tasks at all phases within the process.

Requirements

Bachelor of Science Degree
5-10 years of experience as a Quality Engineer in the healthcare industry, with New Product Development or New Product Introduction experience required.
Must have experience with ISO 13485 and 21 CFR Part 820 Quality System Regulation
Must be able to read and understand 2D detailed part/article drawings
Must understand the use all quality related inspection equipment
Must have excellent problem solving and mistake proofing skills
Must have computer skills and familiarity with Word and Excel programs
Must have knowledge of SPC
Effective interpersonal and problem-solving skills
New product development experience- minimum of 2 years' experience
Established track record in demonstrating strong leadership and managerial skills within a team-based, collaborative matrixed organization

Nice To Haves

Experience with validating large-scale automation
Experience with 21 CFR Part 4 Combination Products

Responsibilities

Create and maintain pFMEA’s, Control Plans, PPAPs, Master Validation Plans, IQ/OQ/PQ protocols and reports.
Analyze FAIRs, process and test method validation data before sending to the customer.
Lead customer complaints and CAPA investigations as required.
Manage ECOs, deviations, and documentation updates as required.
Generate and maintain applicable quality system documentation as needed.
Manages activities for handling healthcare products from receiving to shipping.
Assessing and ensuring compliance through training, auditing, and corrective and preventive actions.
Participate in customer audits and provide input to any observations.
Train personnel as required
Review and discuss daily rejects and implement action plans
Make appropriate changes to prevent recurrence of quality related issues.
Make appropriate changes to fixtures or inspection methods and tools as required.
Regular attendance and professionalism.
Make decisions regarding quality related questions as appropriate
Contact customers via verbal/written communication as appropriate
Participate in design reviews as required
Visit customers and suppliers as required
Participate in plant/department meetings and tours as required
Work with Engineering, Manufacturing and Tooling on continuous improvement activities
Maintain cleanliness of work areas and quality measuring equipment
Observe all health and safety requirements and report any unsafe conditions
Other duties as assigned