03/22/2019 | Chester, NY
The ideal candidate will be able to provide support as Director of Quality and Regulatory Assurance (QA/RA) and bring broad experience through the proactive, risk-based quality tools and management systems.
Essential Job Functions
- Assign and direct QA/RA resources and competencies to support sustaining engineering, new product design, and production needs in a balanced way that is best for customers.
- Responsible for clear evidence of product conformance to specifications, using a risk-based, statistical approach to identify the extent of verification testing and validation needed prior to new product and engineering change releases.
- Responsible for risk-based validation procedure and its application to process/test equipment, test software, test methods, and production processes.
- Conduct statistical data and trend analysis of warranty, defective parts delivered, and customer feedback as critical inputs to customer satisfaction, product performance improvements, and business objectives.
- Provide appropriate and complete response to customer complaints and corrective action requests and assuring best use of corrective action and root cause analysis processes to prevent recurrence.
- Responsible for continuation, improvements, and internal/external audit of the Quality Management system (QMS).
- Responsible for document and records control, including controlled access to documents required to be controlled per QMS and EMS standards.
- Development and implementation of supplier quality management program.
- Provide oversight and support to executive team, including procedure integration, internal audits, and succession planning.
- Provide direction, coaching, development, mentoring, and succession planning for team.
- Implementation of strategic QA roadmap
- Manage department budget, and manage performance to warranty budget, site revenue, etc.
- Provide back-up to team as needed (willing and able to work hands-on).
- Identify and implement tools to improve efficiencies of the quality and regulatory functions.
- Monthly Key Performance Indicators, metrics and reporting
- BS in engineering or another technical/science degree. Master’s degree in science, business or other degree relevant to the position a plus.
- 5+ years of QA experience at a managerial level in manufacturing, assembly, or production environment.
- Proficient in the use of statistical and data analysis tools.
- Demonstrated comprehension of risk-based decision making, verification testing, and validation.
- Medical device or pharmaceutical/GMP a plus.
- Cross-boundary collaboration
- Driving organizational change
- Leading people and teams
- Internal and external customer focus
- Project planning and execution
- Systems thinking
- Technical problem solving
- Effective communication
- Excellent communication, leadership and influencing skills
- Excellent time management and organizational skills
- Ability to work collaboratively or independently as required
- Ability to be flexible and respond well to change in line with business priorities
- Ability to work in a high-demand environment
- Strong organizational and project management skills a must
Repro-Med Systems, Inc., operating as RMS Medical Products, is a leading developer and manufacturer of medical devices and supplies. RMS designs, manufactures and markets proprietary and innovative portable medical devices and supplies, primarily for the ambulatory infusion market and emergency medical applications, in compliance with the FDA quality and regulatory system and international standards for quality system management. The Company’s development and marketing focus is primarily concentrated on (i) its mechanical infusion products, the FREEDOM Infusion Systems (as used with one or more accessories, the “FREEDOM System”) which include the FREEDOM60® Syringe Driver (“FREEDOM60”), the FreedomEdge® Syringe Driver (“FreedomEdge”), HIgH-Flo Subcutaneous Safety Needle Sets™, RMS Precision Flow Rate Tubing™ and RMS Precision Flow Rate Controller, and (ii) its medical suction product, RES-Q-VAC® Portable Medical Suction System (“RES-Q-VAC”). The Company was incorporated in the State of New York in March 1980. The company maintains offices, manufacturing facilities, and warehouse space in Chester, New York. www.rmsmedicalproducts.com
DISCLAIMER: The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position. Therefore, employees assigned may be required to perform additional job tasks required by the manager.
We maintain a drug-free workplace and perform pre-employment substance abuse testing.
RMS Medical Products provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, marital status, pregnancy, parental status, national origin, ethnic background, age, disability, political opinion, social status, veteran status, union membership or genetics.
All positions offer opportunity for advancement. If you have the skills and are seeking a challenging growth opportunity, please e-mail your cover letter, resume and salary requirements to firstname.lastname@example.org or fax to 845-469-5518.
RMS offers a competitive salary and benefits package, including medical, dental, LTD and 401(k).