Sr. Engineer, Quality

Axogen is a healthcare company focused on restoring peripheral nerve function and improving quality of life through innovative medical solutions.
Vandalia, OH, USA
$81,737 - $102,171
Quality
Senior Software Engineer
Hybrid
5+ years of experience
Healthcare · Biotech

Description For Sr. Engineer, Quality

Axogen, a leading healthcare company focused on peripheral nerve function restoration, is seeking a Senior Quality Engineer to join their team. This role combines engineering expertise with quality assurance in a medical device manufacturing environment. The position offers a comprehensive benefits package and the opportunity to make a meaningful impact on patients' lives.

The ideal candidate will bring 5+ years of quality engineering experience in medical device or pharmaceutical manufacturing, along with a strong foundation in engineering principles and quality management systems. You'll lead quality planning activities, participate in product development, and ensure compliance with various regulatory requirements including FDA and ISO standards.

Working at Axogen means joining a company with a clear mission to improve healthcare outcomes. The company offers a collaborative culture that values unique perspectives and professional growth. With a hybrid work model, competitive salary range of $81,737 - $102,171, and extensive benefits including health insurance, 401(k) matching, and stock purchase options, Axogen provides an excellent environment for career development.

Key responsibilities include leading quality planning initiatives, conducting risk management activities, and ensuring regulatory compliance. You'll work cross-functionally with various departments, from Product Development to Operations, making this role ideal for someone who enjoys diverse challenges and strategic thinking in quality engineering.

The position requires occasional travel (up to 30%) and offers the opportunity to directly impact patient care through quality assurance in medical device manufacturing. If you're passionate about healthcare innovation and quality engineering, this role offers a chance to contribute to life-changing medical solutions while advancing your career.

Last updated 2 days ago

Responsibilities For Sr. Engineer, Quality

  • Confer with departments regarding product design to ensure user needs are met
  • Evaluate product design for manufacturability
  • Lead Quality Planning activities for new product development projects
  • Lead and participate in risk management activities
  • Lead Quality issue resolution using root cause methodologies
  • Design and implement inspection methods and sampling plans
  • Ensure compliance with CGMP, QSR, ISO13485, MDD regulations
  • Participate in FDA inspections and ISO Certification audits
  • Establish and implement metrics for monitoring system effectiveness
  • Direct staff as needed

Requirements For Sr. Engineer, Quality

  • Bachelor of Science Degree in Biomedical, Mechanical Engineering, or Engineering Technology
  • Minimum of 5 years in Quality Engineering/Quality Assurance role for medical device or pharmaceutical manufacturing
  • Strong project management skills
  • Knowledge of statistical sampling and analysis
  • Proficient with MS Office Suite, including Microsoft Visio and Project
  • Experience with Quality system regulations (21 CFR part 820, ISO 13485, ISO 9001)
  • Geometric Dimensioning and Tolerance (GD&T) experience
  • Up to 30% travel required

Benefits For Sr. Engineer, Quality

Medical Insurance
Dental Insurance
Vision Insurance
401k
Parental Leave
Education Budget
Equity
  • Health Insurance
  • Dental Insurance
  • Vision Insurance
  • 401(k) matching
  • Paid Time Off
  • 9 Paid Holidays + 3 Floating Holidays
  • Dependent Care Flexible Spending Accounts
  • Medical Flexible Spending Accounts
  • Tuition Reimbursement
  • Paid Parental Leave
  • Paid Caregiver Leave
  • Basic Life Insurance
  • Supplemental Life Insurance
  • Employee Stock Purchase Plan
  • Disability Insurance

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