Quality Engineer - Contract Manufacturing

The Quality Engineer assists in the design and implementation of policies and procedures for testing and evaluating the precision and accuracy of products and/or equipment. The Quality Engineer will be expected to provide support to Operations, interact with customers and provide support for Quality Systems and Process Engineering, managing multiple projects.

This position will be integral in meeting the Quality Management System requirements and new product development. It requires creativity and foresight to work with operations and product development teams to ensure compliance to the Quality Manual, Design Control, Supplier Management and other appropriate procedures for a variety of medical devices from concept through market introduction.

*This is an on-site position in Houston, PA.

Key Result Accountabilities

• Maintain company compliance with FDA Quality Management System Regulations and ISO 13485 standards. Must be able to draft and execute protocols for IQ, OQ, and PQ initiatives relating to new products, new procedures, and process changes.
• Actively participates in internal, customer and third party audits, and other activities covered under Perryman’s Quality Manual, Policies and Procedures.
• Support quality inspectors for production and new products.
• Provide customer-related quality and regulatory inquiry support.
• Compile and write training material and conducts training sessions on quality control activities.
• Provide direction, analysis and recommendations for product development to successfully launch new products into active production in a timely and cost-effective manner. Understand and incorporate customer standards and requirements into internal processes.
• Lead implementation of continuous improvement projects or act as subject matter expert for SPC, FMEA, DOE, and process validation.
• Lead and provide Project Management support as needed.
• Perform measurement system analyses and process capability studies to evaluate test and inspection equipment.
• Lead disposition of discrepant material and devises processes to minimize recurrence.
• Support supplier approval and qualification of new/revised items which includes supplier audits, management of supplier corrective and preventative actions, and development
• Support or perform measuring, testing, and tabulating data concerning quality and reliability.
• Provide DFM feedback to customers to ensure product designs are optimized for manufacturing, inspection and quality requirements.
• Support CMM inspection activities including interpretation and application of GD&T requirements, and coordination with customers on technical and inspection-related matters.
• Lead and/or support CAPA investigations, 8D root cause analysis, and implementation of corrective and preventive actions.
• Support and lead change management activities including, change requests, deviations, and revalidation as required.
• Develop and maintain control plans and risk management documentation to ensure product quality and compliance.
• Lead and support compliant investigations and failures assessments.

Requirements

• Bachelors degree in Engineering or related industrial, scientific, or business field required.
• 2-5 years’ experience in a quality role within a regulated industry, with increasing responsibility preferred.
• Experience in the Medical Device or other regulated industry, such as QSMR and ISO 13485, with increasing responsibility preferred.
• Experience with FDA and ISO 13485 accreditation inspections is a plus.
• Must be adept in use of computer software for the analysis of data, preferably Microsoft Excel and statistical packages (Minitab preferred).
• Quality Engineering certification (CQE) preferred or equivalent body of knowledge in areas which include but are not limited to Statistics, SPC, Geometric Dimensioning & Tolerancing; Sampling, Design of Experiments, etc. Ability to analyze, understand and effectively communicate this technical material. Experience with Lean Manufacturing and Six Sigma is a plus.
• Ability to organize and judge priorities in a dynamic, fast-paced environment and work independently with minimal supervision is critical.
• Must possess excellent verbal & written communication skills, which include but are not limited to presentation, organizational and management skills.