Quality Engineer

At MiMedx, our purpose starts with helping patients heal. We are driven by discovering and developing regenerative biologics utilizing human placental tissue to provide breakthrough therapies addressing the unmet medical needs for patients across multiple areas of healthcare. Possessing a strong portfolio of industry leading advanced wound care products combined with a promising clinical pipeline, we are committed to making a transformative impact on the lives of patients we serve globally.

We are excited to add a Quality Engineer to our Processing Engineering-Tech Transfer team! This role will pay a base salary between $80,000.00 - $98,000.00 based on previous medical sales experience, location, and other factors.

POSITION SUMMARY:

The Quality Engineer is responsible for interacting with other departments to provide qualification support for equipment, critical utilities and facilities as well as validation support for processes. This position is responsible for ensuring site compliance, and all necessary activities are performed on time to keep all validated systems in a validated state, to meet applicable biologics or medical device regulatory requirements and industry standards and maintain the quality and safety of MIMEDX products. Provide evidence that equipment remains in a qualified state following preventive and reactive maintenance, movement, calibration, and change control.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Author and execute documentation for new equipment and facilities, including (but not limited to):
  
  
  
  • Validation Plans
  • User Requirements Specifications
  • Installation Qualification (IQ), Operational Qualification (OQ), and Performance (PQ) Protocols and Reports
  • Validation Summary Reports
  
  
  
  
• Review reactive maintenance, preventive maintenance, and movement work orders. Assess and verify that work performed addresses root cause and is appropriately documented and that affected equipment and facilities remain in a validated state.
• Perform risk assessment and mitigation supporting the attainment and maintenance of a validated state of compliance for equipment, processes, and facilities.
• Perform all work according to regulations, released procedures and cGxPs
• Analyze validation test data to determine whether acceptance criteria have been met
• Identify protocol deviations from established product or process standards and provide recommendations for resolving protocol deviations
• Work with engineering and suppliers to coordinate and execute Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT) activities and protocols
• Prepare detailed reports based on results of validation and qualification tests
• Communicate with affected departments and key stakeholders regarding validation status
• Make updates to Validation Master Plan (VMP) as needed
• Revise or create standard operating procedures related to qualification and operation/maintenance of equipment, as needed
• Conducts all activities in a safe and efficient manner
• Conduct investigations as needed for corrective and preventive actions and nonconformances
• Participate in continuous improvement activities
• May be assigned additional duties projects commensurate with experience
• Manage projects, efforts, and changes of limited complexity and scope
• Assist and support other validation activities and process development activities wherever needed
• Assist with or lead internal investigations of corrective and preventive action
• Participate in continuous improvement activities that directly impact performance measures
• Assist with internal and external audit activities

PROBLEM SOLVING:

• Works on problems of moderate scope which are often varied and routine where analysis of situations or data requires a review of a variety of factors. Exercises judgment within defined procedures and practices to determine appropriate action. Applies learned techniques and contributes to analysis and investigation to solve problems. Normally receives little instruction on day-to-day work, general instructions on new assignments.

DECISION MAKING/SCOPE OF AUTHORITY:

• Independently performs assignments with instruction limited to results expected. Determines and develops approach to solutions
• Receives technical guidance only on unusual or complex problems or issues
• May manage elements/portions of a budget/project

SPAN OF CONTROL/COMPLEXITY:

• Seasoned professional contributor with responsibility for an advanced area of work in the professional field
• May be responsible for entire projects or functions having modest scope/impact or portions of projects having considerable scope/impact to department results

EDUCATION/EXPERIENCE:

• BS degree in Science, Engineering, or related field
• 3-6 years of experience working in an FDA-regulated industry
• Prefer cGMP pharmaceutical industry, biologics industry experience; medical device or tissue processing industries considered
• Prefer progress towards obtaining CQE
• Prefer progress towards obtaining CQA
• Knowledge of FDA, AATB, ISO, and other state/federal/international regulations and standards
• Prefer in-depth knowledge of IQ, OQ, and PQ concepts including range of use and critical quality attributes

SKILLS/COMPETENCIES:

• Excellent oral, written, and interpersonal communication skills
• Proficient in Microsoft Office (Excel, Word, etc.) and Minitab or similar statistical analysis software
• Organized, flexible, and able to multi-task while maintaining a high level of efficiency and attention to detail
• Must show aptitude to develop appropriate skills needed for the job
• Strong attention to detail and analytical skills.
• Excellent communication and teamwork abilities.
• Ability to work independently and prioritize tasks effectively.
• Excellent oral, written, and interpersonal communication skills.
• Organizational, analytical, and problem-solving abilities.
• Effective prioritization and project management skills.
• Background in generating, interpreting, and compiling raw measurement data into validation records and final reports.
• Solid understanding of cGxPs, FDA regulations, and other relevant requirements.

WORK ENVIRONMENT/EXPECTED BUSINESS TRAVEL:

The work is typically performed in a normal office environment. The Role routinely uses standard office equipment. Additional work is conducted within controlled environment areas. The ability to put on, and work in, personal protective equipment such as cleanroom gown/coveralls, gloves, and safety glasses is required.