Quality Engineer

Quality Engineer

W2 Contract-to-Hire

Pay Rate: $40 - $48 per hour

Location: Warsaw, IN - Onsite Role

Job Summary:

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 for design quality to ensure compliance with 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.

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
• 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
• A combination of education and experience may be considered relative to requirements.

Desired Skills and Experience

Clinical Trial Assistant, Clinical Operations, design quality, quality engineering, orthopedic quality engineering, medical devices, new product development, design controls, design history file, DHF, quality management systems, QMS, ISO 13485, 21 CFR Part 820, ISO 9001, ISO 14971, design verification and validation, V&V, regulatory clearance, supplier quality, engineering drawing review, gage development, gage R&R, capability studies, CMM correlation studies, tolerance stackups, PFMEA, process flows, control plans, inspection plans, DHR review, CAPA, SCAR, root cause analysis, DMAIC, Shainin System, Ishikawa, risk management, FMEA, statistical analysis, process control, process capability, Minitab, sampling plans, inspection methods, acceptance criteria, qualified vendors, mechanical testing, packaging, sterilization, special process validation, NX, SolidWorks, CAD, GD&T, cross-functional collaboration, supplier collaboration, regulatory agency communication

Bayside Solutions, Inc. is not able to sponsor any candidates at this time. Additionally, candidates for this position must qualify as a W2 candidate.

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