Responsible for providing leadership, managing, planning, executing and reporting on regulated Quality Assurance activities for internal/external audits. This individual is responsible for performing Internal, domestic and international audits(as appropriate) that ensure compliance with the FDA QSR , ISO, MDD, CMDR requirements, and other worldwide health authority regulations/guidelines, site SOPs, protocols, and industry standards, as applicable. The Auditor acts as a compliance resource and provides recommendations for corrective action and tracks corrective action commitments until closure.
Independently plans, conducts, and documents internal and external audits to assess compliance with the applicable standards and regulations and company SOPs.
Plans, executes and prepares clear and concise written reports of audit or review observations, including an assessment of compliance during internal audits of facility quality systems.
Supports Quality management, which includes ensuring that corrective and preventive actions are issued as required, properly investigated, documented, effective, and completed on time, and that audits are properly performed, documented, and completed in accordance with the annual audit procedure/schedule.
Facilitates and consults with corrective action teams in implementing changes to ensure compliance with all applicable QSR/ISO//MDD/CMDR and other applicable requirements.
Performs re-audits and/or effectiveness verifications as a way of assessing and documenting CAPA Effectiveness
Issues to management timely written audit reports and follows up on audit activities to ensure appropriate corrective action.
Escalates audit findings to the appropriate level of management.
Assists during third party audits.
This is not an inclusive list of job responsibilities.
Required Skills and Abilities:
ISO 13485 Lead Auditor for one year is required.
Minimum of three years Quality Auditing experience conducting and participating in the Medical Device industry is required.
ASQ -CQA (Certified Quality Auditor) is preferred.
Ability to prioritize and multi-task successfully in a fast paced environment
Ability to work both independently and in a collaborative team setting.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability or protected veteran status.
Getinge is an EO employer – M/F/Veteran/Disability
Experience and Education Requirements:
Bachelor’s degree in Engineering or in a scientific or health-related field is required.
Minimum of three years’ experience in Quality Assurance, Quality Engineering or related functions. CQA Certification is preffered. Prior experience in a FDA regulated industry and/or ISO certified organization. Must have strong compliance background in 21 CFR 820, 801, 803, 806 as well as ISO13485, MDD, CMDR, ISO 14971.
Working knowledge of Quality Systems is required. Familiar with analytical software applications is preferred.
Project management and leadership experience is required. Must demonstrate effective influencing and change management skills and demonstrated achievements in process improvements.
Must have strong verbal and written communication skills and demonstrate ability to be able to interact with all levels of an organization for the purposes of gathering data and feedback for investigations.
Must have the ability to understand procedural documents and evaluate these documents to ensure compliance to all applicable regulations and requirements.
Must possess strong organizational skills and demonstrate the ability to work independently.
Ability to use Microsoft Office Products such as Word , Excel, Power Point or equivalent software applications
May require up to 20% travel both domestic and internationally.
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 a...llows 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.