Section I - POSITION TITLE:
Section II - POSITION SUMMARY:
Responsible for promoting and complying with requirements associated with the design and manufacture of needle-free injection systems. Supports the development and enforcement of internal systems and procedures to meet ISO standards, FDA regulations, EU directives, and additional Rest of the World (ROW) regulations for medical devices as they apply to the Company. Establishes and implements monitoring and validation techniques necessary to verify products meet requirements. Prioritizes and implements process improvement projects to drive customer satisfaction, maintain an effective quality management system (QMS), and improve business productivity. Track and report on the effectiveness of the Company’s QMS.
Section III - ESSENTIAL POSITION FUNCTIONS:
- Assists the Director of Quality in QMS maintenance and compliance.
- Assists the Department Leads in Quality Record maintenance and compliance.
- Executes reviews of External Documents (regulations, guidance documents, standards, etc.) to verify the organization is adhering to global State of the Art practices
- Conducts root cause analysis and implementation of corrective actions for product and process-related issues as directed by the Director of Quality.
- Develops and coordinates training programs to build quality awareness.
- Interfaces with Engineering, Regulatory and Operations to ensure appropriate design transfer of new products to production.
- Works with Regulatory and Clinical Affairs in ensuring regulatory Technical Files and Dossiers represent the most current product and organization information.
- Assists the Director of Quality in the development and implementation of contract manufacturer quality plans.
- Assists the Director of Quality and Operations in evaluating contract manufacturer performance.
- On-site and Remote audit of contract manufacturers to the Quality Agreements, ISO standards, and Quality Plan expectations.
- Ensures timely resolution of supplier corrective actions.
- Supports Operations, Engineering and contract manufacturers to ensure products and processes comply with relevant requirements of the QMS and the Medical Device File (Device Master Record).
- Conducts quality audits, including performing internal and supplier audits, preparing audit finding reports and verifying the effectiveness of corrective actions.
- Assists the Director of Quality in creating and maintaining quality system documentation, such as quality manuals, procedures, work instructions, and forms.
- Manages supplier quality performance and development of supplier metrics.
- Plans and directs the activities of equipment calibration activities to ensure all critical measuring and test equipment is accurate and properly functioning.
- Plans, promotes and organizes training activities related to product quality and reliability.
- Coordinates with manufacturing engineering and contract manufacturers in establishing initial and quarterly sterility validation. Support presentation of these results to the Company’s department leads and Top Management.
- Provide clerical support to the Quality and Engineering departments as needed
- Monitor and report on outputs associated with First Article Inspection, In-Process Inspection, and Final Release Testing
- Participate in customer visits and supports the Director of Quality during ISO 13485 audits, FDA inspections, Notified Body conformity assessments, and other ROW regulatory assessments.
- Develops and analyzes statistical data and product specifications to establish standards propose methods to achieve quality system requirements.
- Identifies techniques and technologies to be used in process control and monitoring to improve quality, reduce inspection and increase product throughput with contract manufacturers.
- Participates as needed in product design review and quality planning to meet product specifications.
- Ensures documentation and record requirements of the quality management system are met, including but not limited to compilation of management review data.
NOTE: The above responsibilities and functions are not intended to be an all-inclusive list of duties and standards of the position. Incumbents will follow any other instructions, and perform any other related duties, as assigned by supervision.
Section IV - MINIMUM COMPETENCY REQUIREMENTS:
Relevant Work Experience: A minimum of 2-years’ experience in quality assurance and/or engineering in the medical device industry.
Education Level: Bachelors degree, preferably BS, BSME
Certification/Licensure: ASQ Certified Quality Engineer or Auditor preferred
Other Skills, Knowledge and Abilities:
- Strong background in ISO 13485 system management and thorough knowledge of FDA requirements and other international standards that regulate the medical device industry.
- Ability to handle multiple tasks with various levels of priority; Must be able to coordinate requests from regulatory, project engineering, sales & marketing, engineering, and manufacturing engineering to achieve timely response to specific needs.
- Strong communication skills; must be able to present ideas, results, and requirements effectively throughout the organization on a timely basis.
- Strong trainability: must be able to learn new concepts and implement procedures, work instructions and forms to guide such concepts in the QMS
- Must be familiar with commonly used software packages, including SPC, equipment calibration, word processing and data acquisition.
- Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, Access, Outlook, etc)
- Exposure to a a manufacturing environment.
- Ability to travel to contract manufacturing locations as needed to support planning and implementation of new products and/or processes and conduct compliance assessments.
- ISO 13485 quality management system
- New Hire Orientation
- Applicable QMS procedures