Quality Engineer

Duties and Responsibilities

• Assist all elements of the design control system and DHF creation from a design quality perspective for new product development.
• Help execute within a QA system and team that ensures alignment to the Balmoral QMS while optimizing time to regulatory approval/clearance.
• Work with suppliers to review and drive the following to ensure regulatory clearance and production readiness: engineering drawing review, gage development, capability studies, gage RRs, special process validations, tolerance stackups, CMM correlation studies, PFMEA, Process flows, control plans, inspection plans, and DHR reviews.
• Develops and implements corrective/preventative action plans, internal CAPA's, and supplier SCARs
• Provide verification and validation, sampling, and statistical analysis support for all functions required for product clearance/approval through supplier relationships(eg, mechanical testing, manufacturing special processes, packaging, sterilization)
• Design and implement inspection methods, equipment, acceptance criteria, and sampling plans to support qualified vendors

Requirements and Qualifications

• Knowledge of design control requirements per ISO 13485 and 21 CFR part 820
• Quality system regulations and requirements (i.e., 21 CFR part 820, ISO 13485, ISO 9001, ISO 14971)
• Problem solving using root cause methodologies (i.e., DMAIC, The Shainin System, Ishikawa)
• Knowledge of statistics, process control, and process capability
• Applying statistics and software in data analysis (example: Minitab)
• Application of Risk management ISO 14971 and failure modes and effects analysis (FMEA)
• Use of Computer Aided Drafting Software package (i.e., NX, Solidworks)
• Geometric Dimensioning and Tolerancing (GD&T)
• Inspection methods and limitations based on engineering drawings and associated tolerances
• Able to work within a team environment and build relationships outside of the department, as well as outside the company (suppliers, regulatory agencies, etc.)
• Able to communicate both orally and in written form to multiple levels of the company.
• BS in engineering or an alternative Bachelor's degree program
• 3+ years of experience in an Orthopedic Quality Engineering role