Quality Engineer

Bayside Solutions; Warsaw (IN); On-site; USD 85,000 - 130,000; Full time

Job summary

Bayside Solutions, Inc. seeks an experienced Quality Engineer for Orthopedic Medical Devices to support new product development and design control compliance. You will collaborate across departments to ensure design quality, regulatory readiness, and timely approvals.

The role emphasizes applying quality tools (DMAIC, FMEA, SPC) and working with suppliers to ensure CAPAs, process validation, and robust inspection plans. BS in engineering required with 3+ years in orthopedic quality engineering.

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).
• 3+ years of experience in an Orthopedic Quality Engineering role.
• Combination of education and experience may be considered.

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 engineering drawing review, gage development, capability studies, gage R&R, PFMEA, process validation, and DHR reviews.
• Develop and implement corrective/preventative action plans, internal CAPAs, and supplier SCARs.

Skills

Root cause analysis

DMAIC

Shainin System

Ishikawa diagrams

Statistics

Process capability

Cross-functional collaboration

Written and verbal communication

Education

Bachelor's degree in engineering

Tools

NX

SolidWorks

Minitab

Job description

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

Medical Device Quality Engineering, New Product Development, Design Quality, Design Controls, Design History Files (DHF), Quality Management Systems (QMS), ISO 13485, ISO 9001, ISO 14971, 21 CFR Part 820, Regulatory Compliance, Regulatory Clearance, Supplier Quality Engineering, Supplier Management, Engineering Drawing Review, Gage Development, Gage R&R, Capability Studies, Process Validation, Special Processes, Tolerance Stack-Up Analysis, CMM Correlation Studies, PFMEA, Process Flows, Control Plans, Inspection Plans, Device History Record (DHR) Review, CAPA, SCAR, Root Cause Analysis, DMAIC, Shainin System, Ishikawa Diagrams, Verification and Validation, Mechanical Testing, Packaging Validation, Sterilization Validation, Statistical Analysis, Statistical Process Control, Process Capability, Sampling Plans, Minitab, Risk Management, FMEA, Inspection Methods, Acceptance Criteria, NX, SolidWorks, GD&T, Orthopedic Medical Devices, Project Planning, Cross-Functional Collaboration, Supplier Relations, Written and Verbal Communication

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