Supports Service Operations and Management, which includes the establishing of processes, procedures, metrics and reporting.
Create Standard Operating Procedures to maintain practical, efficient compliance to all Regulatory requirements.
Communicates, interacts and coordinates quality improvement efforts with Service Leadership, QA Leadership for the USA Service processes and products.
Establishes key metrics and an overall scorecard for Service processes and results.
Analyzes Servicing activities and data to identify and lead improvement opportunities.
Supports CAPA management, which includes ensuring that corrective and preventive actions are issued as required, properly investigated, documented, effective, and completed on time.
Partner with internal resources to ensure internal audits are properly performed, documented, and completed in accordance with the annual audit procedure/schedule.
Performs supplier Control functions for all externally supplied installation activity or Servicing.
Reviews and approves product/process documentation in the standard change control system.
Investigates process nonconformances by conducting failure investigations and promptly reporting on investigation results.
Acts as a key driver of change within the organization, supporting Service team members and leaders by communicating process improvement efforts to employees and help them learn, understand, adjust, and grow with the organization's continuous improvement initiatives.
Assess Service processes and tools for their ability to meet customer requirements including capability, reliability, and robustness.
Provides leadership, mentoring, and training to all levels and functions within the Service Organization in the use of continuous improvement, lean and six sigma methodologies.
Coordinates technical activities regarding Service process validations: including protocol development, synchronization of interdepartmental activities, evaluation and reporting results
This is not an inclusive list of job responsibilities.
Bachelors degree in Engineering, Science or related field is required. A Masters of Science in Engineering, Science or related field is preferred. CQE (Certified Quality Engineer) or CQA (Certified Quality Auditor) is desirable.
Minimum of five years experience in quality assurance, quality engineering or related functions or a M.S. plus 3 years experience is required. Prior experience in a FDA regulated industry or ISO certified organization.
Must have demonstrated proficiency in statistical analysis, the ability to analyze and solve complex problems, and the ability to communicate effectively across departments.
Working knowledge of quality systems is required. Familiarity with analytical software applications is preferred.
Project management and leadership experience is required. Previous experience participating in FDA/customer/corporate audits is preferred.
Must demonstrate effective influencing and change management skills and demonstrated achievements in process improvements.
Must have demonstrated presentation, facilitation skills and the ability to interact and communicate with senior management and Sales/Service/Field staff at all levels.
Must have effective problem-solving, decision making, influencing and negotiation skills as well as the ability to assess the impact of regulatory strategies on business performance.
We will also consider candidates that have experience with the following:
Being an ISO 13485 Lead Auditor for one year.
Leading CAPA projects.
Previous experience participating in FDA/customer/corporate audits.
Experience clearly defining the methods for complying with FDA regulations that apply to Quality Systems and Manufacturing Systems software.
Getinge Group is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, pregnancy, genetic information, national origin, disability, protected veteran status or any other characteristic protected by law.
Getinge Group is a leading global provider of products and systems that contribute to quality enhancement and cost efficiency within healthcare and life sciences. The aim is to be the most desired medtech company in the world.
Getinge's offering is mainly targeted at care providers, care givers and care receivers. The offering to hospitals is organized in three areas: Enable, Treat and Care. This... allows Getinge to identify customer issues at an early stage, promote clinical and economic benefits and follow and support the customer decision process. Getinge's unique offering mirrors the hospital's organization and value chain, and the solutions are used before, during and after the patients' hospital stay.