We Make Life More Rewarding and Dignified Location: ?Ballina?Department: ?Quality Summary:A member of the global Quality Leadership Team, the position will provide Quality leadership for the Ostomy, Continence Care, Distribution and Supplier/Contract Manufacturing Quality Teams to achieve business objectives.
They will strive for a dynamic Culture of Quality to continuously improve our products, processes and Quality Management System (QMS) to best fulfil our Mission and Vision and make life more rewarding and dignified for the people who use our products.
They will directly oversee the Quality Assurance activities for all manufacturing plants, distribution centers and supplier/contract manufacturing personnel.
This position will be located at one of our Hollister mnaufacutirng facilities (Stuarts Draft, VA; Ballina, Ireland; Kaunas, Lithuania; or Bawal, India).
Responsibilities:Provide Quality Assurance leadership to the facilities Quality Managers at our Global operation locations as well as Distribution Quality, Supplier Quality and Contract Manufacturing groups.Responsible for ensuring quality assurance related processes and products are compliant with all applicable regulatory requirements and standards.
Responsible for the oversight, measuring (KPIs) performance and continuous improvement of the processes within responsibility Drives continuous improvements initiatives to the highest standards of quality assurance, quality control and supplier management for world class products.
Collaborate with manufacturing & Plant Quality Assurance Manager(s) to ensure achievement of existing quality levels of manufactured products and seek methods to continually improve quality outcomes including leading on cost of quality initiatives.Drives cross site standardization of similar processes and test methods related to quality operations when appropriate and in compliance with regulatory requirements.
Drives the development of risk-based sampling strategies aligned with regulatory requirements,In conjunction with QLT, develop and execute an overall strategy for QA function ensuring communication to key stakeholders for alignment.Fosters a Culture of Quality within the team and cross functionally.Ensures appropriate support is provided during internal and external audits/inspections.Responsible for maintaining professional development plans and coaching of all direct reports including annual goal setting.
Decision making authority with respect to product quality in consultation with key stakeholders.As part of Hollister's Global Quality Leadership Team (QLT), the position holder will attend QLT meetings as required.
Develop and advise on the continuous improvement of quality system processes and procedures.
Maintain a healthy quality system for sites of responsibility.Build and deliver effective communications at all levels while displaying active listening skills.Provide leadership in change management and risk assessment for process / product changes.Advise and participate in IT solutions for quality system improvements.Participate in due diligence audits regarding potential product acquisitions.
Ensure training is provided pertaining to good manufacturing practices (FDA, ISO and MDSAP countries)Where required, Act as liaison with all regulatory agencies including FDA, HPRA and notified body NSAI as needed.Responsible for achieving competency in all identified skill requirements outlined in associated training profile for position.Other duties and tasks as assigned.Essential Functions of the Role:Communication/LeadershipManagement of Talent Development and Employee EngagementBudget ManagementStrategic Planning and DeploymentAbility to interface with a computer for a long period of timePublic speaking requirementsSignificant reading requirementsConstant utilization of listening skills, both person to person and over the phoneWork Experience Requirements:Number of Overall Years Necessary: 12-15Minimum of 8 years' experience in a Regulated industry with Demonstrated Quality Assurance leadership, preferably in the medical device industry.
Plant experience in a Quality management role required.
Corporate experience in a senior management leadership role with domestic/international plant responsibility preferred.
Experience handling facility regulatory inspections (i.e.
FDA, notified body) preferred.
Education Requirements:Bachelor's /Third Level degree in Quality/Science/Engineering or a related discipline is required.Advanced degree is desirable.Specialized Skills/Technicl Knowledge:Extensive experience working in Medical Devices.Hands on experience ensuring compliance with: Quality Management system elements and associated regulatory requirements (ISO 13485, ISO 14971, CFR 21 FDA 820, MDD/MDR etc.
).Experience with statistical sampling plans based on risk management.
Basic knowledge of sterilization.Greenbelt certification preferred with knowledge of Lean and Six Sigma methodologies required.Knowledge of ERP Systems preferred.Strong in Microsoft Office suite, especially Excel.Knowledge of internal & external audit management with proven experience in representing a company in interactions with notified body/Regulatory agencies.
Working knowledge of continuous improvement and root cause problem solving in a manufacturing setting.Demonstrated ability to project manage and execute tasks in a timely and efficient manner.Must be able to communicate (both written and verbal) at all levels of the organization and with customers, suppliers and regulatory agencies.Good interpersonal skills with the ability to work as part of a cross functional team.Excellent analytical skills with an ability to define problems, analyze through data collection/fact finding and draw valid conclusions in a timely manner.Fiscal ManagementHave a continuous improvement mindset and demonstrated change management skills.
Local Specifications:English About Hollister IncorporatedHollister Incorporated is an independent, employee-owned company that develops, manufactures and markets healthcare products worldwide.
The company spearheads the advancement of innovative products for ostomy care, continence care and critical care, and also creates educational support materials for patients and healthcare professionals.
Headquartered in Libertyville, Illinois, Hollister has manufacturing and distribution centers on three continents and sells in nearly 80 countries.
Hollister is a wholly owned subsidiary of The Firm of John Dickinson Schneider, Inc., and is guided both by its Mission to make life more rewarding and dignified for people who use our products and services, as well as its Vision to grow and prosper as an independent, employee-owned company, and in the process, to become better human beings.EOE StatementAll qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.Job Req ID: 34503