Quality Engineer (Medical Device)

Primary Role

Provide lead quality support for New Product Development Teams to ensure new/improved medical device products and processes are in compliance with applicable standards and regulations. Responsible design quality to ensure compliance to design control systems. Plan and lead projects by identifying and organizing activities into time dependent sequencing with realistic timelines. Work effectively/ productively with all departments by developing a team atmosphere.

Key Responsibility

• 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, 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 (e.g. – mechanical testing, manufacturing special processes, packaging, sterilization)
• Design and implement inspection methods, equipment, acceptance criteria and sampling plans to support qualified vendors

Qualification

• 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
• Ability 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
• Combination of education and experience may be considered relative to requirements

Travel Requirements

20% travel may be required

Pay: $45.00 - $50.00 per hour

Work Location: On the road

Salary : $45 - $50