What are the responsibilities and job description for the The Quality Assurance Engineer II position at Regenity Biosciences?
Position Summary/ Objectives
The Quality Assurance Engineer II reports to the Sr. Director, Quality or Manager, Quality Assurance/Engineering and will be responsible for managing elements of the quality system in alignment with business, regulatory, and customer needs.
This position ensures that the outputs of the Design and Development, Production and Process Control, Risk Management, and other related processes are compliant and technically sound. The incumbent will have design control and process development experience, strong problem-solving skills, understanding of statistical techniques, and strong analytical skills to support product development, transfer, improvement, and maintenance.
The Quality Assurance Engineer II will represent the Quality Assurance/Control teams on multiple projects including new product development, contract development/manufacturing, and design/process changes for existing devices. This role will also be a key contributor to ensuring the overall effectiveness of the Quality Management System.
Essential Job Functions:
About
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. While performing the duties of this job, the employee is occasionally required to stand, walk, sit, and file records. The employee must occasionally lift or move office products and supplies, up to 50 pounds.
Regular travel between Collagen Matrix sites and for off-site training or customer meetings may be required.
Supervisory Responsibilities
This position does not manage staff but does oversee associated projects/programs.
Education, Experience and Certification:
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.
Regenity Biosciences is an Equal Opportunity Employer. We consider applicants for all positions without regard to race, color, religion, creed, gender, national origin, age, disability, marital or veteran status, sexual orientation or any other legally protected status. Regenity Biosciences celebrates the diversity of our team. We believe that talent, drive, and experience are the only relevant criteria for considering new team members.
The Quality Assurance Engineer II reports to the Sr. Director, Quality or Manager, Quality Assurance/Engineering and will be responsible for managing elements of the quality system in alignment with business, regulatory, and customer needs.
This position ensures that the outputs of the Design and Development, Production and Process Control, Risk Management, and other related processes are compliant and technically sound. The incumbent will have design control and process development experience, strong problem-solving skills, understanding of statistical techniques, and strong analytical skills to support product development, transfer, improvement, and maintenance.
The Quality Assurance Engineer II will represent the Quality Assurance/Control teams on multiple projects including new product development, contract development/manufacturing, and design/process changes for existing devices. This role will also be a key contributor to ensuring the overall effectiveness of the Quality Management System.
Essential Job Functions:
- Participate and make meaningful contributions to the design and development process including review of inputs, application of risk management, determining suitability of outputs, review/approval of verification/validation protocols/reports, ensuring effectiveness of design transfer, and adequacy of design reviews
- Engage with R&D and Engineering teams to ensure effective transfer of production processes from design to manufacturing including review/approval of specifications, batch records, and other documentation, participating in process FMEA(s), review/approval of equipment and process qualification/validation documents, ensuring facility readiness, and other activities as required
- Partner with Process/Quality Engineering to ensure robust data analysis, evaluation of results, and decisions to take action (e.g. CAPA)
- Develop and update procedures, specifications, and standards for internal products and processes to support continuous improvement initiatives within the applicable QMS elements from above.
- Provide support during External Audits (government agencies, notified body, customer, etc.)
- Work with internal partners and customers to understand contract development and manufacturing needs and proper application of CMI’s QMS
- Identify and lead improvements to the Quality Management System to increase effectiveness and streamline business processes
- Effectively utilize Microsoft Office software to create reports, spreadsheets, and presentations
- Assist with various special ad hoc projects and other duties as assigned
About
- Integrity - We act in all ways with respect and transparency, ethically and honestly, with everyone. Our work represents who we are, as we create products we can proudly recommend to our loved ones.
- Collaboration - We are only successful together, operating as one diverse and inclusive team with each other and our customers.
- Determination - We are passionate, dedicated, and tenacious about our goals.
- Creativity - We are passionate trailblazers, relentless in our pursuit of continuous improvement.
- Moved by Urgency - Patients depend on us delivering our products with enthusiasm, efficiency, and diligence. Our obligation and privilege is to drive urgency on patients’ behalf.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. While performing the duties of this job, the employee is occasionally required to stand, walk, sit, and file records. The employee must occasionally lift or move office products and supplies, up to 50 pounds.
Regular travel between Collagen Matrix sites and for off-site training or customer meetings may be required.
Supervisory Responsibilities
This position does not manage staff but does oversee associated projects/programs.
Education, Experience and Certification:
- B.S. in engineering or related scientific field plus 3 5 years of experience in a Quality Engineering or related QMS role
- Master’s degree, certification as a quality engineer (CQE), and auditor certification are highly desirable
- Ability to collaborate with a crossfunctional team and build strong relationships within and outside the company
- Practical application of QSR/ISO regulations including design controls, FMEA, production, and process controls
- Understanding of statistics including sampling, control charting, and process capability
- Strong investigative and problemsolving skills
- Ability to prioritize and multitask in a high energy fastpaced environment
- Strong verbal and written communication skills to all levels within and outside of the company
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.
Regenity Biosciences is an Equal Opportunity Employer. We consider applicants for all positions without regard to race, color, religion, creed, gender, national origin, age, disability, marital or veteran status, sexual orientation or any other legally protected status. Regenity Biosciences celebrates the diversity of our team. We believe that talent, drive, and experience are the only relevant criteria for considering new team members.
