08/04/2021
Vivorté is searching for an individual with medical device experience to help the team navigate and execute design and process controls. This individual will be responsible for implementing development projects into Vivorte’s Quality Management System and supporting changes to current marketed products. This individual will work cross-functionally with other departments to assure proper validation and verification activities, and act as a liaison between product development and quality/regulatory divisions.
This role is responsible for providing technical engineering support to new product development teams and sustaining manufacturing / operations teams. This individual is expected to apply knowledge of design and process control principles and quality engineering techniques to design, transfer and manufacturing activities. As a member of one or more cross-functional teams, this individual will assist in mitigating risks throughout the product’s life cycle and preparing design and process verification and validation protocols and reports. In parallel, this person shall ensure products are developed in accordance with applicable regulatory requirements, customer expectations and industry standards.
As in any small company, all employees may be required to assist with business development, testing, manufacturing, documentation, regulatory, and clinical.
Additional duties may be assigned to this position on an as needed basis to ensure success of the company.
KEY RESPONSIBILITIES
· Provide quality guidance pertaining to manufacturing, product development, international registration, design and process controls, etc.
Support product lifecycle management.
Perform DMR and DHF compliance assessments to ensure quality and regulatory requirements are successfully implemented and maintained.
Utilize statistical process control methodologies to achieve required levels of product reliability.
Support design/process verification and validation studies on new products and existing products. Plan and execute re-validation and/or verification activities when process improvements are made to existing products.
Collaborate with internal departments and external groups to assure appropriate quality requirements.
Execute a risk-based approach to design requirements/specifications, technical standards, test methods, supplier controls and manufacturing controls complying with appropriate regulations, standards and guidelines.
Coordinate, assess impact and implement supplier changes.
· Assess the regulatory risk associated with change documents
Create test protocols, work instructions and reports for improved processes as required by the FDA and ISO standards for regulated medical devices.
Support new product transfer from development to production.
Active participation during internal and external audits and ensure compliance with all ISO/FDA requirements for medical devices.
Support Operations in day-to-day production activities including but not limited to receiving inspection of product components, manufacturing of component and finished goods, batch release testing and inspections.
Must be able to reach, bend and lift up to 35 lbs on a daily basis.
May need to work in a bench setting, lab setting, manufacturing floor or clean room environment.
Perform other duties assigned as needed.
CANDIDATE QUALIFICATIONS & PROFESSIONAL EXPERIENCE
BA/BS degree in engineering or science curriculum required; advanced degree preferred.
Two plus years in QA/Regulatory or Design with medical device company; orthopedic or biologic experience a plus.
Demonstrated knowledge of FDA Quality System Regulation, ISO 13485 Quality Management System and ISO 14971 Risk Management for Medical Devices.
Thorough understanding of implementation of design and process controls and changes.
Experience in complying with Design and Process Controls requirements and expectations.
Experience working with new product design / development projects or sustaining engineering projects.
Excellent knowledge of regulatory design/development requirements.
Knowledge and familiarity with engineering product development and commercialization.
Understanding of mechanical and biologics engineering a plus.
Familiarity with mechanical drawings, quality systems, documentation and record keeping, ISO 9000, ISO 13485 and/or cGMP 21 CFR a plus
Working knowledge of Microsoft Word, Microsoft Excel, Windows
Able to constructively collaborate with cross-functional teams.
Vivorte, Inc. is an Equal Opportunity Employer. Vivorte does not discriminate on the basis of race, religion, color, s*x, gender identity, s*xual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need.
