RBW Consulting are partnered with a well-established CDMO who are excited to be expanding their team. We are looking for an experienced Quality Engineer to join the Devens, MA site.

With over 30 years industry experience, they present fantastic career progression opportunities and working with complex pipelines of both Medical Device and Pharma products.

You'll be 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.

Essential Job Duties and Responsibilities:

• Create and maintain pFMEAs, 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 complaint and CAPA investigations as required.
• Manage ECOs, deviations, and documentation updates as required.
• Generate and maintain applicable quality system documentation as needed.
• Manage activities for handling healthcare products from receiving to shipping.
• Assess and ensure 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.
• Maintain regular attendance and professionalism.

Essential Qualifications:

• Bachelor of Science Degree.
• 10 years of experience as a Quality Engineer in the healthcare industry.
• Experience with ISO 13485 and 21 CFR Part 820 Quality System Regulation.
• Ability to read and understand 2D detailed part/article drawings.
• Proficient in using all quality-related inspection equipment.
• Excellent problem-solving and mistake-proofing skills.
• Proficient in computer skills and familiar with Word and Excel programs.
• Knowledge of SPC.
• Effective interpersonal and problem-solving skills.
• Proven track record in demonstrating strong leadership and managerial skills within a team-based, collaborative matrixed organization.
• Excellent written, verbal, and presentation skills.