Quality 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 Engineering, Quality Systems and Process engineering.
This position will be integral in meeting the Quality Management System requirements. 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. The ideal candidate is a self-motivated individual who is excited by the prospect of working in a dynamic, fast-paced environment.
Key Result Accountabilities
Maintain company compliance with FDA Quality System Regulations and ISO 13485 standards. Experience with FDA and ISO inspections and registration is a plus. Must be able to write and perform protocol for IQ, OQ, and PQ for new products, new procedures, and process changes.
Actively participates in internal audits, management review and other activities covered under Perryman Quality Manual, Policies and Procedures.
Manage or train inspectors for production and new products.
Provide customer-related quality and regulatory inquiries’ support.
Compiles and writes training material and conducts training sessions on quality control activities.
Provide QE direction, analysis and recommendations for Product Development to successfully launch new products into active production in a timely and cost effective manner. Directs development and maintenance of internal/external standards relative to Design and Development,
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.
Performs measurement system analyses to evaluate test and inspection equipment.
Leads disposition of discrepant material and devises process to assess product quality and reliability.
Support supplier approval and qualification of new/revised items which includes inspection method development and validation as well as correlation with supplier’s methods, supplier audits, management of supplier corrective and preventative actions and assist in FMEA.
Support for FDA and ISO inspections and registration.
Root cause analysis – scrap, pareto, action plans
Supports or may perform measuring, testing, and tabulating data concerning quality and reliability.
2-7 years experience in the Medical Device or other regulated industry, such as QSR and ISO 13485, with increasing responsibility.
Experience with FDA and ISO 13485 Certification 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.
Must possess excellent verbal & written communication skills, which include but are not limited to presentation, organizational and management skills.
About Perryman Company
Located in Houston, PA, Perryman Forge & Fabrication is a certified ISO 13485:2003, ISO 9001:2008, and AS9100 Rev C facility offering medical device contract manufacturing. We specialize in machining titanium, stainless steel, aluminum, cobalt chrome, and medical grade plastics for implants, trials, and instruments.
Our forging operation offers high quality, low- to mid- volume products in an array of titanium, cobalt chrome, and stainless steel shapes. Perryman Forge & Fabrication specializes in adding value through machining, finishing, and managing outside processing vendors to provide a finished product for our customers. We also forge intermediate items for our customers to process further at their facility.
We offer the highest quality at a competitive price by implementing lean principals, such as SMED, KANBAN, and 5S, throughout the entire organization.