Hill-Rom is the leading manufacturer and supplier of medical technologies and related services for the health care industry. Their products include patient support systems, safe mobility and handling solutions, non-invasive therapeutic products for several acute and chronic medical conditions, medical equipment rentals, surgical products and information technology solutions. Hill-Rom's products and services are used by health care providers across the health care system and around the world in hospitals, extended care facilities and home care settings to improve patient safety and the quality of patient care.
 William A. Hillenbrand founded Hill-Rom in 1929, William had the dream of “bringing the home into the hospital”. Since then, Hill-Rom has grown their business both organically and through several acquisitions across the globe, making Hill-Rom an industry leader and a trusted partner to health care providers, patients and caregivers around the world. Today Hill-Rom has approximately 10.000 employees worldwide and their products are sold in more than 100 countries. In 2016 the company had a turnover of USD 2.7 billion, an increase of 34 percent. This includes contributions from the recent Trumpf Medical and Welch Allyn acquisitions, as well as strong organic performance. Hill-Rom is headquartered in Chicago, USA, with subsidiaries with global coverage The Hill-Rom share (HRC) is listed on the NYSE, the shares has been listed since 1978. Company mission: “Every day, around the world, we enhance outcomes for our patients and their caregivers.”

 

Quality Assurance & Regulatory Affairs Director TILLSATT

The QA/RA Director is the quality leader for Manufacturing Operations (“entity”), the plants, and support facilities, and is the designated Quality Management Representative for all aspects of Quality System implementation within the manufacturing facilities. This role provides leadership to all functions within the Lulea, Sweden Operation to enable the organization to achieve Quality goals as well as aggressive growth objectives. The QA/RA Director is responsible for the achievement of Quality scorecard metrics and operational targets, corrective actions, and the implementation and maintenance of an effective and compliant Quality System.

The role is based in Luleå and reports to the VP QA/RA Director PSS (Patient Support System).

Responsibilities
• Lead, coach, and develop a team of QA/RA professionals.
• Serve as Quality Management Representative for the manufacturing facilities, including hosting third party inspections and audits, and organizing and conducting periodic Management Reviews of the Quality System.
• Provide strategic direction and leadership to all functions and levels of the manufacturing organization to ensure operations adhere to the highest standards of compliance and product quality.
• Direct the implementation of corrective and preventive actions, ensuring timely and robust completion of actions to enterprise targets. 
• Ensure product containment of manufacturing non-conformances, to include immediate correction activities as appropriate and determination of systemic corrective and preventive actions.
• Review complaint trending and drive actions to improve customer experience and lower complaints.
• Chair the local Corrective Action Board (CAB) and participate in the Global CAB.
• Oversee all aspects of supplier quality for the plants, including 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 all applicable regulations and corporate requirements.
• Intelligently deploy resources to meet daily business needs in a timely manner while evolving the quality system to become more proactive, efficient, and effective.
• Manage the entity Master Validation Plans, ensuring IQ (Installation Qualification), OQ (Operational Qualification), and PQ (Performance Qualification) of existing, new, or modified equipment, processes or non-product software.
• Prepare and adhere to annual operating budget.

Required profile
We are looking for a highly skilled leader with a solid QA and RA background and with excellent ability to gain and maintain trust from others and to engage and motivate an organization.

Education and experience
• Bachelor’s degree in a related medical, science or regulatory discipline required.  Engineering degree / product development experience strongly preferred.
• 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 (quality system requirement), CMDR (Canadian Medical Device Regulations) and Medical Device Directive
• ISO Quality System and other applicable industry requirements is required.
• 10+ years in the medical device industry or related GMP environment or equivalent.
• 5+ years of experience leading direct reports.

Competencies and skills
• 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 respond to enforcement actions, voluntary or official, as may be needed from time to time.
• ASQ Certifications for Auditing and/or Quality Management is preferred

For further information about the position please contact Jarl Molin or Sara Steinvall, Recruitment consultant at PeakSearch.

Contact information:
e-mail: jarl.molin@peaksearch.se
mobile: +46-(0)70-560 20 56

e-mail: sara.steinvall@peaksearch.se
mobile: +46 70 204 37 42
office: +46 8 545 00 100