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Sr Manager Quality Assurance / Regulatory Affairs

About Our Company NP Medical Inc., a subsidiary of Nypro, a Jabil company, is an innovator and supplier of medical devices that address the large-scale needs of the infusion therapy and vascular access markets. The goal that motivates us every day is to provide compelling product solutions that make quality patient care possible by improving patient outcomes and caregiver safety at an affordable cost. It is a deep understanding of the consequence of our work that has fueled NP Medical's product innovation, guided our daily operations, and defined our customer and caregiver engagement for over thirty years. This rich tradition has produced an enduring and winning culture marked by excellence, compassion, and collaboration that extends to our customers, caregivers, and patients alike. Position Summary The NP Medical Sr Manager of Quality Assurance and Regulatory Affairs is the business partner directly responsible for crafting a quality and regulatory strategy that assures fulfillment of our mission to make quality patient care possible in a compliant, effective, and least burdensome manner. This is achieved in part by directing the activities of the Quality/Regulatory department to ensure the efficacy of the NP Medical Quality Management System to the satisfaction of all the stakeholders we serve, depend on and by whom are held to account: patients, end users, customer, regulatory bodies, suppliers, and each other. Essential Duties & Responsibilities Actively contributing to the NP Medical executive staff and company strategic direction Behaving and driving achievement in accordance with NP Medical's PRIDE values. Implementating and maintaining the NP Medical Quality Management System in compliance with FD&C Act, 21CFR820, MDD, ISO13485, CMDR Responsible for Management Responsibilities (Management Review, Quality Objectives, Quality policy), Quality Engineering, Design Quality Assurance, Quality Systems, Supplier Quality, Complaint Management, Incoming and Finiahed product Quality, Document Control, Non-conforming Materials (MRB). Championing ISO 14971 Risk Management compliant processes Managing and prioritizing the team's workload in accordance with organizational and departmental goals Providing guidance to staff to interpret changing priorities, processes and regulatory requirements. Leading the development of SOPs and work instructions and associated quality tools to improve product quality and to increase work efficiency Translating strategic goals into group and individual performance objectives Recognizing and Rewarding accomplishments in accordance with NP Medical's PRIDE values and behaviours. Identifying opportunities for improvement and developing processes to ensure regulatory compliance and process robustness. Oversight of the compilation and review of organizational Quality metrics to identify potential gaps or adverse trends. Support creation of Regulatory strategy and submission of 510(k) and EU Technical files. Drive resolution/improvements to implementation through direct contribution or by facilitating working teams. Collaborate and Influence cross functional peer leaders in order to obtain support for process improvements Continually monitor the regulatory environment and evolving FDA expectations and adjust strategies and processes accordingly. Developing staff and conduct mid-year and annual reviews of staff Lead audits/Interface with customers and regulatory representatives Supports learning opportunities and mentors others, encourages employees to take on stretch assignments. Lead by being an agent for change and questioning the status quo Education & Experience Requirements At minimum, a Bachelor Degree in a scientific discipline 8 -10 years experience in Medical Device design and manufacturing Demonstrated ability and commitment to continual improvement Previous leadership experiencerequired, with experience in managing multiple levels of staff is preferred. (4-5 years direct leadership experience.) Thorough understanding of the US & EU Quality and Regulatory requirements (i.e. 21CFR820, ISO 13485, etc.) Well-developed communication skills A Masters degree in a related field is preferred CQM,RAC, Six Sigma beneficial Knowledge Requirments Ability to read, analyze, interpret and communicate regarding scientific and/or technical journals, financialreports, and legal documents. Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community. Highly skilled and practiced at working with higher mathematical concepts, including probability and statistics. Advanced skills at budget creation, forecasting and budgetary adherence. Ability to effectively present information to top management, public groups, and/or boards of directors Ability to look at market demands and quality/regulatory trends, technology information and projections, and forecast advanced quality/regulatory needs a minimum of 1-2 years forward. Strong knowledge of global and regional quality and regulatory requirements is preferred. Experience with own brand label/private label regulatory requirements. Strong proficiency in determining company's business goals and objectives with ability to devise and implement strategy to achieve targets. Proven track record of successful change management accomplishments, implementing and management continuous improvement and cost reduction programs. Proficiency in use of personal computers, Microsoft Office products (Excel, Word and PowerPoint) and e-mail skills required. 212134
Salary Range: NA
Minimum Qualification
8 - 10 years

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