Posted in Other 30+ days ago.
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Type: Full Time
Location: Caledonia, Michigan
Hillrom is a $2.8B leading worldwide manufacturer and provider of medical technologies and related services for the health care industry, including patient support systems, safe mobility and handling solutions, non-invasive therapeutic products for a variety of acute and chronic medical conditions, medical equipment rentals, surgical products and information technology solutions. Hillrom's comprehensive product and service offerings are used by health care providers across the health care continuum and around the world in hospitals, extended care facilities and home care settings to enhance the safety and quality of patient care.Description
The Quality Director is the designated Quality Management Representative (QMR) for all aspects of Quality System implementation within the Aspen Surgical manufacturing facility. This role provides leadership to all functions within the Organization to achieve Quality goals as well as aggressive growth objectives. The Quality Director is responsible for achieving Quality scorecard metrics and operational targets, corrective actions, and the implementation and maintenance of an effective and compliant Quality Management System.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Individual must possess proficient interpersonal and communication skills to interact cross functionally and must be able to communicate effectively with senior management, Hill-Rom Legal, external resources, and suppliers.
- Serve as Quality Management Representative for the manufacturing facility, including hosting third party inspections and audits, and organizing and conducting periodic Management Reviews of the Quality System.
- Provide strategic direction and leadership to the QA Organization to ensure activities adhere to the highest standards of compliance and product quality.
- Direct the implementation of corrective and preventive actions, ensure timely completion of actions to appropriate targets.
- Ensure product containment of manufacturing non-conformances, to include immediate corrective activities as appropriate and the determination of systemic corrective and preventive actions.
- Chair the Local Corrective Action Board.
- Oversee supplier quality activities for the manufacturing facility, including the support of supplier selection, qualification, and control.
- Manage the device history record process including localized document control activities.
- Identify and mitigate gaps between Quality System requirements and applicable regulations and corporate requirements.
-Bachelor's degree in a related medical, science or regulatory discipline required. Engineering degree strongly preferred
- 8+ years in the medical device industry or related GMP environment or equivalent.
- 3+ years of experience leading direct reports.
- Demonstrated strong proficiency with Microsoft systems (Excel, PowerPoint, Word, and Project).
- Thorough knowledge and understanding of medical device regulations and standards, including but not limited to QSR, CMDR, Medical Device Directive and the EU Medical Device Regulation
- Experience in the ISO Quality System and other applicable industry requirements is required.
- Excellent verbal and written communication skills, including attention to detail; strong questioning and listening skills; and the ability to look beyond obvious answers in order to understand the impact on other areas is required.
- Exceptionally strong leadership and influencing skills.
- Must have the ability to make effective presentations to all levels of the organization.
- The proven ability to prioritize and manage multiple projects and meet deadlines is required.
- Must have the ability to work in both a collaborative (team) environment as well as perform independent work as required.
- Experience building a high performance team, managing performance of team members with varying levels of skill and experience, and mentoring high potential individuals to achieve greater impact on the organization.
- Strong appreciation of the impact of regulatory bodies on medical device product lifecycle is required.
- Experience working with diverse cultures and employees.
- Strong knowledge of tools and techniques for failure investigations.
- Successful track record for identifying and implementing systemic corrective and preventive actions.
- Knowledge of equipment and process validation requirements.
- High degree of individual ownership and accountability.
- Ability to manage regulatory agency inspections and responses to enforcement actions, voluntary or official, as may be needed from time to time.
- ASQ Certifications for Auditing and/or Quality Management is desirable.
- Occasional ( 20%) overnight travel is required based on business need and may include international travel.
Hillrom is an equal employment employer F/M/Disability/Vet/Sexual Orientation/Gender Identity