Hillrom Services Inc.
Milwaukee, WI, United States
Manager, Quality, Engineering, Sciences
Jan 12, 2022
Apr 27, 2022
Quality Systems Manager','22122081','!*!Hillrom and Baxter have united, creating one of the world’s leading medical products companies. We are committed to our shared vision to transform healthcare. We're building on the legacy and strengths of two historically innovative and socially responsible companies that—when joined together—should better serve our patients, customers and communities. This is an exciting time to join us as we begin a new chapter, together.No matter your role at Baxter, your work makes a positive impact on people around the world. You can expect to work with caring people who value relationships. Our teams are strong and empowered because we value differences. This is where you can do your best work and thrive in an international environment. This is where you can belong. ','!*!Position Summary: The Quality Systems Manager is responsible for maintaining the integrity of quality management system, ensuring the QMS remains updated and complaint with applicable regulations, standard updates and QMS optimization for organizational success.
Ensure the proper functioning and continued effectiveness of Quality System procedures, maintaining compliance with required standards and regulations (e.g. ISO 13485, ISO 9001, FDA QSR, MDD, Canadian MDR, etc.).
Acts as primary Subject Matter Expert on Quality Management Systems for Hillrom.
Leads development and implementation of improvements to the Quality Management System across the organization, including site integration into sector and corporate global procedures.
Provide leadership, direction, and training to Quality System procedures.
Ensure corrective and preventive action system is effective and oversees the CAPA program and site CAPA review Board (CRB). Ensures linkages between site-level CRB and corporate Global CRB.
Oversee Notified body (GMED) communications and request and ensure timely responses, also provide support to regulatory representatives of Cardiology on matters related to QMS reports for product registrations.
Develop Management review presentations with inputs from all stakeholders and coordinate Management Review Meetings.
Primary representative for activities and communications associated with internal, customer and regulatory audits performed at Hill-Rom; ensure resolution of reported non-conformances.
Maintains the internal audit plan/schedule and coordinates audit activities to ensure company requirements are met. Acts as Lead Auditor for internal audits.
Oversees document control process and training assignments related to QMS procedures.
Mentor in quality systems and quality tools for the organization.
Write, review, and approve quality system documents.
Assist in preparation of annual budget request.
Performs other duties as requested.
Bachelor of Science degree in engineering, business or a related field.
At least 8 years relevant experience within the regulated industries.
Certified Lead Auditor training by notified body or relevant experience.
Experience with regulatory audits (FDA, ANVISA, etc.); Notified Body audits (DQS, GEMD, BSI, etc.) and Certification Testing Laboratories (Intertek, UL, etc.)
Proficient in the Microsoft Suite: Excel, Word.
Training In corrective actions (CAPAs).
American Society of Quality Certification.
Fluent in English (both written and oral).
Ability to read written electrical schematics.
Excellent written and verbal skills, strong analytical skills.
Leadership skills and abilities:
Ability to lead others and get results through others.
Ability to develop employees beyond their current abilities and manage workload.
Ability to delegate.
Behavior skills and abilities:
Proactive, systems thinking approach.
Ability to work under minimal supervision.
Ability to work well in groups.
Ability to work in a fast-paced high stress environment and ability to remain calm under pressure.
Good listening skills.
Open to new ideas, creative, ability to learn new skills and concepts easily, flexibility and adaptability, good organizational and planning skills, and detail orientated.
','!*!Hillrom is an equal employment employer F/M/Disability/Vet/Sexual Orientation/Gender Identity. #INDHR','Quality','United States-Wisconsin-Milwaukee','','Full-time','Yes, 10 % of the Time','Welch Allyn','Welch Allyn','Quality Systems Manager
Hillrom Services Inc.
Website : https://hillrom.com/