Sr. Engineer, Quality

ISPE International; Vandalia (OH); On-site; USD 90,000 - 130,000; Full time

Job summary

Axogen in Ohio is seeking an experienced Sr. Quality Engineer to provide quality and compliance support across development, manufacturing, and distribution of healthcare products in line with GMP, QSR, and ISO13485.

The role requires a BS in engineering, 5+ years in QA for medical devices or pharma, strong project management, FMEA, and statistical analysis; travel up to 30% and collaboration with cross-functional teams.

Qualifications

• Bachelor of Science in Biomedical, Mechanical Engineering, or Engineering Technology.
• Lean manufacturing and quality disciplines experience.
• Design controls, project management, and manufacturing practices knowledge.
• 5+ years in a Quality Engineering/Quality Assurance role for medical devices/pharma.

Responsibilities

• Coordinate with Product Development, Clinical, Marketing, Sales and Operations on design to meet user needs.
• Evaluate manufacturability and suggest design/process improvements.
• Lead risk management activities and FMEA.
• Drive quality planning for new product development and facility validation.
• Lead quality issue resolution using root cause analysis.
• Ensure CGMP, QSR, ISO13485 compliance and regulatory readiness.
• Prepare data reports and present findings to management.
• Collaborate with suppliers to ensure product quality.
• Support FDA inspections and ISO certifications.

Skills

Lean manufacturing

Quality disciplines

Design controls

Project management

Statistical analysis

Minitab

FMEA

GD&T

MS Office

Root cause analysis

Supplier management

CGMP

QSR

ISO13485

FDA inspections

Lead auditor

Six Sigma Black belt

ASQ Certified Quality Engineer

Education

Bachelor of Science in Biomedical Engineering

Tools

MS Visio

MS Project

Job description

Axogen Mission and Business Purpose

Our business purpose is to restore health and improve quality of life by making restoration of peripheral nerve function an expected standard of care. We aim to lead the markets we serve by always requiring the solutions we offer patients and caregivers provide an improved benefit-to-risk profile as compared to existing standards of care. To ensure we deliver improved benefit-to-risk solutions, we will guide and expect the market and design requirement specifications underlying our engineering, business development, and clinical research activities, objectively target advancements in standards of care.

Job Summary of the Sr. Engineer, Quality

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.

Requirements of the Sr. Engineer, Quality

• 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 (i.e. Minitab)
• Application of failure modes and effects analysis (FMEA)
• Experience 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
• Desirable but not required:
  • ASQ Certified Quality Engineer
  • Lead auditor certification
  • Six Sigma Black belt
• Travel Requirements are up to 30%

Responsibilities of the Sr. Engineer, Quality

The specific duties of the Sr. Engineer, Quality include but are not limited to:

• 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.