Now part of the Hill-Rom family of companies, Mortara Instrument is the fastest-growing company in its field and the number two provider of ECG devices in the world. With operations in Australia, Germany, Italy, the Netherlands, and the United Kingdom, Mortara distributes its innovative products worldwide to physician offices, clinics and hospitals. Its offerings include electrocardiographs, cardiac stress exercise and rehabilitation systems, Holter systems, data warehousing solutions, and patient monitoring systems. With a deep commitment to both its customers and community, Mortara is proud of its unique, “Built with Pride in Milwaukee” philosophy, which is the driving force behind its commitment to manufacturing products in the U.S. Mortara also offers an excellent benefits package including health, dental, disability and life insurance, flex spending and health savings accounts, paid time off/paid holidays, and a 401(k)-retirement plan with employer match.
Position Summary: The Quality Systems Manager is responsible for management, administration and continuous improvement of the documented quality management system.
- 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 Mortara.
- Leads development and implementation of improvements to the Quality Management System across the organization.
- Provide leadership, direction and training to Quality System procedures.
- Oversees the CAPA program and site Corrective Action Board (CAB). Ensures linkages between site-level CAB and corporate Global CAB.
- Ensure proper functioning of corrective and preventive action system and effectiveness of changes implemented.
- Oversees and provides education in quality and quality tools for the organization.
- Primary representative for activities and communications associated with internal, customer and regulatory audits performed at Mortara; 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.
- Provides metrics related to quality system processes and quality objectives for Management Review.
- Write, review and approve quality system documents.
- Assist in preparation of annual budget request.
- Performs other duties as requested.
- Bachelors of Science degree in engineering or a related field.
- At least 8 years relevant experience within the regulated industries.
- Certified Lead Auditor training or relevant experience.
- Experience with audits (FDA, Notified Body and Certification Testing Laboratories).
- American Society of Quality Certification.
- Proficient in the Microsoft Suite: Excel, Word.
- 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.
- Ability to delegate.
- Behavior skills and abilities:
- Ability to work under minimal supervision.
- Ability to work well in groups.
- Ability to work in a fast-paced high stress environment.
- Calm under pressure.
- Good listening skills.
- Open to new ideas, proactive, ability to learn new skills and concepts easily, flexibility and adaptability, good organizational and planning skills, and detail orientated.