Overall goal of the position:

Maintenance and advancement of Osypka AG quality system with specific emphasis on the R&D processes.

 

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 specifically within the context of R&D processes
  • Promote the general understanding for and the acceptance of quality requirements within the company’s R&D group by devising and conducting regular trainings and workshops and coaching individual members of the group if needed
  • Provide QM-support to R&D and OEM projects and act as the main quality contact within OEM projects
  • Set up and negotiate quality agreements with OEM customers
  • Review R&D documents for QM compliance
  • Perform gap analyses on new or updated regulatory requirements and subsequently develop project plans for closing of any identified gaps specifically within the context of R&D processes and OEM projects
  • Create and regularly update key quality documents such as quality manual, SOPs etc.
  • Plan and conduct internal audits
  • Organize and accompany audits by OEM customers and handle follow-up tasks
  • Assist in preparation of and accompany audits by Notified Bodies and regulatory bodies
  • Issue non-conformity reports, conduct root cause analyses and define and implement CAPAs
  • Take part in FMEAs and risk analyses according to ISO 14971
  • Assist in 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
  • Provide general assistance to the QM department as needed

 

Qualification:

 

  • Vocational education or University Degree in Engineering 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, preferably in the medical devices industry and with a specific focus on R&D processes
  • Auditing experience
  • Proficient in both German and English
  • Good writing skills

 

Personal Qualities:

 

  • Experienced practitioner with an engineering background and very pronounced QM-affinity
  • 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
  • Strong personality, who knows how to motivate people and get them involved in projects but who is also not afraid to persistently demand for requirements to be met and tasks to be completed
  • Very committed employee who works independently and has the ability to prioritize and self-organize, especially under a heavy workload
  • Good interpersonal and communication skills

 

Our offer:

 

We offer you an interesting, varied and versatile workplace, as well as performance-oriented remuneration in our privately managed company, which has been producing innovative and partly unique medical devices for more than 40 years.

 

Quality Manager R&D/OEM (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