Overall goal of the position:

 

Supporting and deputizing the Head of Quality in all aspects of quality management.

 

Specific tasks:

 

  • Plan, implement and advance the company’s quality system according to ISO 13485, FDA QSR, ANVISA RDC 16/2013 and other international regulatory requirements
  • Promote the general understanding for and the acceptance of quality requirements within the company’s workforce by devising and conducting regular trainings and workshops
  • Coach key staff such as managers, supervisors and group leaders in the implementation of specific quality requirements within their area of responsibility
  • Perform gap analyses on new or updated regulatory requirements and subsequently develop project plans for closing of any identified gaps
  • Create and regularly update key quality documents such as quality manual, SOPs etc.
  • Set up the yearly internal audit program and plan and conduct internal audits
  • Organize and accompany audits by Notified Bodies, regulatory bodies and customers
  • Issue non-conformity reports, conduct root cause analyses and define and implement CAPAs
  • Set up quality agreements with suppliers and customers together with purchasing and sales department
  • Provide QM-support to R&D and OEM projects
  • Take part in FMEAs and risk analyses according to ISO 14971
  • Assist in reporting of medical device incidents and complete notifications to regulatory bodies
  • General communication with Notified Bodies, regulatory bodies, customers and suppliers
  • Lead and support quality management related projects, such as implementing new or updated regulatory requirements

 

Qualification:

 

  • Vocational education or University Degree in Engineering, Economics or similar relevant field
  • Additional education in quality management and related fields advantageous
  • Minimum of 5 years experience in all major aspects of quality management within the medical devices industry and in-depth knowledge of the relevant regulatory requirements specifically ISO 13485 and 21 CFR 820 and preferably of additional international regulations such as Japanese PMD, Brazilian RDC 16/2013 etc.
  • Experienced trainer and workshop leader
  • Auditing experience (internal and supplier audits)
  • Proficient in both German and English
  • Good writing skills

 

Personal Qualities:

 

  • Experienced practitioner with solid theoretical background
  • Very hands-on person who fully understands that a smaller sized company does not strive for excellence in all fields of quality management but rather wants to achieve compliance to regulatory requirements within the limits of the available resources
  • Knows how to drive projects forward and closes them successfully
  • Knows how to motivate people and get them involved in projects
  • Very committed employee who works independently and has the ability to prioritize and self-organize, especially under a heavy workload
  • Empathic personality and strong motivator with excellent interpersonal and communication skills

 

Quality Manager/Deputy Head of Quality (m/f/d) 

 

We look forward to hearing from you and are waiting for your application for this job advertisement!

By e-mail to jobs@osypka.de
or by post:

OSYPKA AG
Human resources
Earl H. Wood Straße 1
79618 Rheinfelden-Herten