A Leading medical device contract manufacturer with 20 sites globally, a majority located in the USA, is seeking a Quality Engineer for this NH Site.
As the Quality Engineer you will assist 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.
- Exhibits the company Values in all activities
- Maintain company compliance with FDA Quality System Regulations and ISO 13485 standards.
- Actively participates in internal audits, management review and other activities covered under the company's Quality Manual, Policies and Procedures
- 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
- Develops and initiates standard methods for inspection, testing, and evaluation, utilizing knowledge in related engineering fields
- Devises sampling procedures and designs and develops forms and instructions for recording, evaluating, and reporting quality and reliability data
- Performs measurement system analyses to evaluate test and inspection equipment
- Leads disposition of discrepant material and devises process to assess product quality and reliability
- Monitors and directs engineering group on calibration requirements and implementation of systems to support equipment calibration
- Lead 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
- Direct support for FDA and ISO inspections and registration
- Support and Participate in Continuous Improvement activities
- Support and Participate in activities that increase the ratio of value added to non-value added processes
- Demonstrates leadership through mentoring of junior staff and responsiveness to business needs to achieve positive results
- Demonstrates technical ability through the application of engineering skills, approaches and knowledge
- All other duties as assigned
- BS degree in engineering, a technical or scientific discipline; or with exception, CQE certifications / 6 plus years’ experience
- 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
- 3-8 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
- Strong written and verbal communication skills
- Ability to work well independently and with fellow team members
- Attention to detail and organization skills
- Computer skills with proficiency in Microsoft Outlook and Microsoft Office, Minitab preferred
Kristen Grant - firstname.lastname@example.org
BS degree in engineering, a technical or scientific discipline; or with exception, CQE certifications / 6 plus years’ experience
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