Sr. Engineer, Quality

Axogen•Vandalia, OH

1d•$84,190 - $105,237•Onsite

About The Position

The Sr. Quality Engineer will provide Quality and Compliance related support for the development, manufacture and distribution of healthcare products in accordance with applicable Quality Management regulations (International and Domestic regulations for Biologic, Human Tissue, Medical Device products). The Sr. Engineer exercises independent judgment in engineering methods, techniques and evaluation criteria for obtaining results, creates formal networks involving coordination among groups, and has broad expertise or unique knowledge in Engineering. The Sr. Engineer may have a small group of direct reports and uses skills to contribute to development of company objectives.

Requirements

Minimum of Bachelor of Science Degree in Biomedical, Mechanical Engineering, or Engineering Technology
Lean/Progressive Manufacturing and Quality disciplines.
Fundamental understanding of design controls, project management, and basic manufacturing practices/processes
Minimum of 5 years in a Quality Engineering/Quality Assurance role for medical device or pharmaceutical manufacturing.
Strong project management skills required.
Demonstrated knowledge of statistical sampling and analysis.
Demonstrated excellent organizational, writing and verbal communication skills
Proficient with the MS Office Suite, including Microsoft Visio and Project.
Limit gauge design for dimensional verification.
Problem solving using root cause methodologies (i.e. DMAIC);
Applying statistics and software in data analysis (example Minitab)
Application of failure modes and effects analysis (FMEA);
Working with suppliers to design inspection systems and resolve quality issues.
Quality system regulations and requirements (examples 21 CFR part 820, 21 CFR Part 1271, 21 CFR Part 210/211, ISO 13485, ISO 9001, ISO 14971)
Geometric Dimensioning and Tolerance (GD&T) experience

Nice To Haves

ASQ Certified Quality Engineer
Lead auditor certification
Six Sigma Black belt

Responsibilities

Confer with external and internal departments (example Product Development, Clinical, Marketing, Sales, and Operations) concerning product design to ensure user needs are met.
Evaluate product design for manufacturability and suggest design process adjustments and quality improvements
Engage in the selection, development, and qualification/validation of tools, fixtures, machinery, and equipment used in manufacturing
Lead and participate in risk management activities.
Lead Quality issue resolution by applying root cause methodologies.
Ensure effective design control and transfer to production.
Lead Quality Planning activities for new product development projects, including verification and validation plans and reliability strategies.
Lead Quality Planning activities in Facility development including verification and validation plans and reliability strategies
Lead Quality Planning activities for new and existing processes, including verification and validation plans and reliability strategies.
Investigate manufacturing processes for non-conformance reduction and inspection optimization
Determines quality improvement parameters by identifying statistical methods relevant to manufacturing processes.
Prepares reports and presentations by collecting, analyzing, and summarizing data; making recommendations.
Maintains professional and technical knowledge by attending educational workshops; reviewing professional publications; establishing personal networks; benchmarking state-of-the-art practices; participating in professional societies;
Collaborate with supply chain partners to assure quality of product.
Confer with purchasing and logistics to maintain the supplier management program.
Design and implement inspection methods, equipment, acceptance criteria and sampling plans.
Initiate or assist in cost reductions of product inspections.
Provide validation, sampling, and statistical analysis support to other functions in the organization.
Perform First Article Inspections to ensure Manufacturing process capability.
Ensure compliance with CGMP, QSR, ISO13485, MDD, and other applicable regulations/standards
Participate in FDA inspections, ISO Certification, surveillance audits and customer audits
Deploying proactive quality controls for consistent and predictable quality outcomes
Establish and implement metrics for monitoring system effectiveness
Report to management on quality issues, trends and losses
Provide functional support as needed for all team members
Direct staff as needed