Quality Engineer will provide Quality and Compliance related support to the manufacture and distribution of medical devices in accordance with applicable medical standards and regulations (ISO 13485, 21 CFR 820, etc.).
Technical support for and final review and approval of customer complaint investigations
Support new product development
Facilitate the execution of Risk Management activities
Identify statistically based sampling plans for inspections and validations
Support validations for new and existing products, processes and equipment
Ensure compliance with cGMP, QSR, ISO13485, MDD, and other applicable regulations/standards
Participate in FDA inspections, ISO Registration and surveillance audits and customer audits
Identify and implement opportunities for continuous improvement
Interact and coordinate activities with other departments, external vendors and customers
Assist or lead in the identification and implementation of CAPA
Aid in the implementation SPC control system with Manufacturing and Quality Control
Supports internal quality system audits
Provides support necessary for supplier controls, including but not limited to: supplier audits
Participates in Post-Market Surveillance (PMS) activities as required
Collection and reporting of metrics and data as required
Performs other Quality System related duties as required
The requirements listed below are representative of the knowledge, skill and/or ability required for this position.
Education: BS degree in Engineering, Science (Biology, Chemistry, Physics, etc.), or Math (Statistics)
Certification: Certified Quality Auditor (ASQ CQA) or Certified Quality Engineer (ASQ CQE) would be a plus
Minimum of two years of Quality Engineering experience in a manufacturing or industrial environment, preferably in an FDA regulated environment
Knowledge of statistical sampling and analysis
Knowledge of ISO, FDA, and QSR concepts and guidelines as well as other national and international regulations and standards
Ability to read blueprints and interpret Geometric Dimensioning and Tolerancing (GD&T)
Experience performing quality audits and utilizing manufacturing processes, techniques, and continuous improvement methodologies (i.e, Six Sigma, Lean Manufacturing, etc.).
Knowledge of various MS Office applications such as: Word, Excel, and Powerpoint, including Microsoft Visio and Project
Excellent organizational, written, and verbal communication skills
Strong interpersonal skills and ability to work with others in a positive and collaborative manner
Strong problem solving, leadership, and analytical skills
Outstanding attention to detail
Must be able to observe company policies and safety procedures at all times
Must be able to treat others with respect; work with integrity and ethically; uphold organizational values
Additional Salary Information: Salary competitive based upon experience
Spectra Medical Devices, Inc. was founded in 1995 and is a market leader in manufacturing custom procedural needles.
Spectra Medical Devices has become one of the largest procedural needle manufacturers in the world, with substantial market share in over 20 countries. Spectra utilizes the latest state-of-the-art manufacturing, measuring and inspection systems, along with over 200 years of senio...r staff needle manufacturing experience.
Spectra has been awarded several US patents for special needle processing and product. Our primary focus is on patient safety, achieving substantial growth through quality and innovation. Spectra has four manufacturing plants worldwide employing over 200 personnel. Our corporate headquarters is located in Wilmington, Massachusetts.