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At Getinge we have the passion to perform

Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge, our passion is to secure that every person and community have access to the best possible care, offering hospitals and life science institutions products and solutions that aim to improve clinical results and optimize workflows. Every day we collaborate to make a true difference for our customers - and to save more lives. Are you looking for an inspiring career? You just found it.

At Getinge, we exist to make life-saving technology accessible for more people. To meet future expectations and perform at our best, we need Team players, Forward thinkers and Game changers. Located in the beautiful Inverness Business Park, Getinge offers a generous benefit package (including access to health insurance, time off accruals and 401k participation - day of hire), a robust PTO program and fully supports the "work/life balance" philosophy.

As an FDA and ISO-regulated business, an NDA is required.This is a 5-day/week, on-site position.

Hourly Range:$28 - $35

Job Function Summary: The Quality Supervisor is responsible for managing the daily functions of the Quality operations pertaining to the production of manufactured product, including Medical Devices. Responsible for oversight of the Quality Laboratory and review and completion of all in-process quality checks pertaining to a Device Master Record. Responsible for determining effectiveness of quality systems and analysis of departmental needs. Responsible for direct supervision of receiving inspector and quality laboratory. The Quality Supervisor will have direct reports including QC Laboratory Technicians and Quality Control Floor Technicians.

Job Functions: * Make essential quality decisions regarding received in, in-process, or final release items in accordance to FDA and ISO 9001 regulations. * Manage flow of quality work and determine priorities * Train or cross train employees on quality related jobs * Write Part Specifications for new components/products * Reviewing and signing as final responsible party for Change Orders related to Products, raw materials or quality procedures. * Operation and use of calipers, micrometers and other measurement equipment and tools. * Operation of any other equipment necessary to assure that components and products meet specifications. * Performance of receiving methods for all in-coming items. * Performance of inspection methods for all in-coming components. * Performance of inspection methods for all screen printing, lamination, cutting, and packaging components and assemblies. * Performance of First Article inspection methods. * Inspection acceptance criteria decisions for all in-coming and in-process components and assemblies. * Non-Conforming Item Report processing. * In process floor inspections including verification of Device History Record and Pick List documentation. * Verification of Corrective Actions resulting from Non-Conformities. * Final review of Temporary Authorization for Deviations, inspection of correct performance of TADs and Reworks. * Other QC duties as designated by the QA Director. * Monitor team schedules and authorize Overtime as necessary. * Coach team on performance training and development. * Responsible for timely completion of 90-Day and Annual Appraisals. * Counsel and administer Performance Communications (corrective actions) as necessary, with the assistance of Human Resources

Required Knowledge, Skills and Abilities: * In-depth knowledge of ISO 13485 and FDA 21CFR820 requirements. Knowledge of EU MDR beneficial * Analytical mindset with strong problem solving skills * High level of attention to detail and accuracy * Strong computer skills, including MS Office applications (Word/Excel) and Microsoft Project are required * Proficiency in relevant software applica ions (e.g., document management systems, quality management systems) is a plus * Demonstrated leadership experience with the ability to lead and develop a team, drive accountability, and foster a culture of quality and compliance * Excellent communication and interpersonal skills, with the ability to effectively collaborate with cross-functional teams, regulatory agencies, and external stakeholders

Minimum Requirements: * Bachelor's Degree or equivalent work experience * A minimum of five years related Quality Management experience in an FDA regulated environment

Quality Requirements: * Build Quality into all aspects of their work by maintaining compliance to all quality requirements. * Ensure compliance to all FDA and Worldwide Quality & Compliance regulations (As applicable to the job function). * Must have the education and experience to understand and comply with U.S. and Worldwide medical device regulations (As applicable to your job function). * Attend all required Quality & Compliance training at the specified interval. * Adopt the "Beyond Compliance Quality Culture" in the work environment; always meet and exceed requirements.

Environmental/Safety/Physical Work Conditions: