Quality Systems Engineer

Humacyte, Inc. is bringing to market a once in a generation scientific technology platform, bioengineering readily available and universally implantable product opportunities focused on improving lives of patients and transforming the practice of medicine. Located in Durham, NC, the company develops and manufactures acellular tissues for the treatment of diseases and conditions across a wide range of therapeutic areas. The company’s innovative technology supports tissue repair, reconstruction, and replacement while overcoming limitations in existing standards of care. Initially developing a portfolio of human acellular vessels (HAVs), to target multiple vascular markets including trauma, arteriovenous access for hemodialysis, peripheral arterial disease, and coronary artery bypass grafting. Humacyte is focused on the development of future markets such as pediatric heart surgery, delivery of cellular therapies, and multiple other novel cell and tissue systems. 

We are looking for additional colleagues to continue to build our expanding team.  Candidates will be expected to work both independently and collaboratively as part of the Humacyte organization. Applicants must be highly self-motivated, with solid communication skills, and demonstrates the ability to work in a team environment and lead other professionals and peers.

Position Background:

The Quality Systems Engineer assists in developing quality policies and provides support to the overall technical aspects of the Quality Assurance program at the site. Ensures Quality Management Systems (QMS) are within cGMP and GTP regulations and company procedures and leads within QMS as a process owner and/or subject matter expert. Support internal and external inspections.

This position reports to Associate Director, Quality Systems

Major Accountabilities:

• Ensure comprehensive understanding of the organizational objectives and identify how to translate those into strategies and tactics for implementation in Quality engineering
• Owns, facilitates and administers a variety of quality related process and applications (including training and document management)
• Design, continuously analyze and improve elements of the owned quality system
• Develops, implements, and delivers training on owned quality systems, procedures and GMPs.
• Ensure training curricula are maintained and made contemporary as job scopes change within the organization
• Establish a competency-based training program to ensure SOPs, Job Aids, etc have built in assessments to ensure training competency
• Develop and maintain metrics and trending reports of the quality systems using a variety of statistical analysis tools. Share analysis of data and trending reports with manager or other appropriate colleagues and develop recommendations for utilizing data effectively
• Supports internal and external inspections, participating in inspection readiness activities and addressing document requests in accordance with company policies.
• Evaluate and update existing quality management systems, procedures and processes for cGMP compliance and compliance to corporate policies and procedures
• Represent quality function on project teams as a quality system subject matter expert, supporting process changes and improvements, with the objective to assure that departmental quality objectives are met
• Other duties, as assigned

Special Competencies:

• Advanced understanding of Quality Management System strategies and the ability to write SOPs, Work Instructions and related training.
• Excellent problem solving, decision-making ability, and interpersonal skills that enables conflict resolution as related to technical situations is desired
• Ability to resolve processing challenges within Quality Management Systems through expertise, collaboration and influencing
• Demonstrated ability to work effectively within a team to set goals, develop sound work plans, monitor and communicate progress, and report technical and compliance progress in scientific and industry-standard terms, as required
• Routinely communicate findings and information to peers and other team members; transparency and knowledge sharing is expected and practiced
• Proficient with Microsoft Office applications
• Detailed oriented, self-motivated and scientifically driven
• Demonstrated ability to work in a cross functional team

General Competencies:

• Able to communicate effectively in English, both verbally and in writing

• Possess a positive roll-up-the-sleeves attitude and optimistic outlook

• Represents the organization in a positive and professional manner

• Strong ability to work in a fast-paced team environment with fluctuating priorities, and collaborate effectively with others

• Excellent organizational and time management skills with ability to set own priorities in a timely manner

• High degree of flexibility and adaptability

• Basic computer skills required, such as knowledge of MS Word, Excel, PowerPoint, and Outlook

• Must be able to work as needed to meet tight deadlines and at peak periods

• Self-motivated and organized critical thinker with solid interpersonal and business communication skills

• Demonstrated ability to work in a cross functional team

• Adheres to company and facility specific policies and procedures, including SOP, training and meeting requirements

• Always observe safety precautions and regulations in all areas where duties are performed

• Responsible for reporting all safety hazards and potential unsafe working conditions

• Reports to work on time and as scheduled

QUALIFICATIONS:

• Minimum five years of relevant pharmaceutical, biotechnical or medical device industry experience (includes Document Administration, Quality Assurance, regulated system administration, training development and delivery)
• Process Excellence experience
• Strong understanding of cGMP, ISO and ICH guidance’s in the pharmaceutical, biotechnical or medical device manufacturing environment
• Demonstrated background in support of GMP Quality management systems
• Experience executing validation plans and reviewing and writing validation protocols, reports and technical documents
• Experience in evaluating technical quality problems and providing recommendations for corrective actions
• Firm understanding of Quality Management Systems processes and the ability to lead investigations
• ASQ certification a plus
• Experience conducting Process / Design Failure Mode Effects and Analysis is an asset
• Familiarity with inspection methods and techniques is an asset

Perks:

• Stock Options
• 401k Plan with Matching
• Medical, Vision and Dental Plans
• Long Term/Short Term Disability
• Life Insurance
• 23 Days Paid Time Off (PTO)
• 12 Paid Holidays
• Paid Parental Leave Policies

**Please note, Humacyte does not provide sponsorship at this time.**