Description Starkey Hearing is hiring a Quality Systems Specialist I on it's Quality team in Operations.
If you have experience verifying and maintaining compliance with Federal and International regulations, and for improving QMS (quality management system) through system certification (ISO 13485), as well as meeting global QMS requirements this may be your next career move.
Starkey is a world leader in the manufacturing and distribution of advanced hearing technologies.
We are in the business of connecting people and changing lives.
Our teams come to work each day focused on ensuring people everywhere have the products and services they need to hear better and live better.
Founded in 1967 by Bill Austin, Starkey is known for our cutting-edge hearing health innovations, industry-leading research and development, and not being afraid to push the edge of what's possible.
We are headquartered in Eden Prairie, Minnesota, have over 5,000 employees in 29 facilities across the globe, and do business in more than 100 markets worldwide.
Watch this video to see more of what sets Starkey apart.
https://youtu.be/9cUYwTlCepg?si=wkovx8_R_iINfrc6
This position is responsible for verifying and maintaining compliance with Federal and International regulations, and for improving QMS (quality management system) through system certification (ISO 13485), as well as meeting global QMS requirements.
Job Responsibilities Assist Quality Systems management to manage global CAPA system and drive continuous improvements.
Schedule and manage HQ for CAPA; Record all meeting notes and actions; Manage CAPA database: Update CAR status and reporting agenda; Follow up with pending CARs; Assist internal audit activities per ISO 13485, 21CFR820, MDR and MDSAP and other applicable QMS requirements.
Audit the quality system on a periodic basis to verify compliance.
Track and support completion of all action items resulting from internal audits.
Schedule and organize Manage Review activities.
Assist QMS management to coordinate global QMS activities and support needs from all Starkey facilities.
Host regulatory global QMS meetings and activities.
Drive actions to establish and maintain unified global QMS system.
Provide education, verification and maintenance for the ISO 13485.
Coordinate educational/informational meetings with managers and supervisors.
Ensure and verify that all internal and external requirements are being completed on time and in compliance with guidelines.
Provide up-to-date information to proper personnel on regulatory changes to ensure that requirements are met.
Comply with FDA 21CFR820 rules, regulations and guidelines.
Maintain GMP's (Good Manufacturing Practices) according to FDA guidelines.
Verify compliance with regulations by regularly monitoring internal system.
Assist FDA investigators with information collection and interpretation during FDA audits.
Maintain required approvals, facility registrations and export certificates.
Support new product development and homologation activities.
Support the development of regulatory requirements, manage documents and records, and coordinate required testing.
JOB REQUIREMENTS Minimum Education, Certification and Experience Requirements Education Four-year degree required.
Education in Engineering or Science preferred.
Master's degree (MS, MBA) preferred.
Experience Quality Systems Specialist I: Minimum 3-5 years' experience in related field required.
Knowledge / Technical Requirements Knowledge of GMP and FDA 21CFR820 required.
Knowledge of MDR required.
Knowledge of ISO 13485 criteria required.
Familiarity with production functions required.
Competencies, Skills & Abilities Ability to lead group meetings/presentations required.
Previous experience working within a Quality System (Medical Device or Pharmaceutical) Critical thinking and problem solving Good attention to detail WORK CONTEXT Working Conditions
Normal office conditions
Equipment Operation Normal office equipment #LI-KS1
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant.
However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information.
41 CFR 60-1.35(c)