If you want to work for an organization that values customer focus, teamwork, respect, integrity, communication and innovation, apply now!
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 Sr. Quality Engineer will be expected to provide support to Operations, interact with customers and provide support for Engineering, Quality Systems and Process engineering.
Specializations may include but are not limited to: design control; material and process control; product reliability; software quality engineering; and/or metrology.
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
Maintain company compliance with FDA Quality System Regulations and ISO 13485 standards. Experience with FDA and ISO inspections and registration is a plus.
Actively participates in internal audits, management review and other activities covered under Accellent 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.
Directs workers engaged in measuring, testing, and tabulating data concerning quality and reliability.
All other duties as assigned.
Up to 20% travel may be required.
Environmental Working Conditions:
Normally works in an office environment although expected to be in the machine shop or the assembly area regularly and frequently. Incumbent will be subject to environmental conditions existing in all these areas.
Employee must comply with all safety policies and safe work procedures established by the company. Job tasks may also involve:
Using personal protective equipment such as safety glasses, goggles, gloves, and other equipment as established in company policies and safe work procedures. Working near cutting & machining fluids, solvents, lubricants and other hazardous chemicals using appropriate safety controls.
Employee will be expected to attend safety training, and may serve on the facility safety committee and participate in hazard analysis and resolution.Qualifications:
level 8 in either Science or Engineering is required.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
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.
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.