Overall goal of the position:

Implement and advance the company’s internal audit and supplier evaluation processes as instruments to identify weaknesses and risks within the QMS and supply chain.

 

Routine tasks:

  • Set up the annual internal audit program and the annual supplier audit program in collaboration with purchasing department
  • Plan and conduct all internal audits at the 3 company sites in Rheinfelden
  • Plan and conduct supplier audits together with purchasing department
  • Perform for-cause audits internally and at suppliers and subcontractors in case of acute quality problems
  • Perform process audits on major R&D projects at critical design stages and after manufacturing transfer
  • Represent and explain the company’s internal and supplier auditing processes during customer and regulatory body audits
  • Assist in preparation for Regulatory Body audits
  • Set up meetings with auditors and auditees to discuss audit findings and possible actions
  • Work closely with CAPA Manager and other departments in initiating follow up actions from audits such as NCRs, Root Cause Analyses and CAPAs and monitor due dates
  • Create and update SOPs and work instructions related to auditing processes
  • Train co-auditors for internal and supplier audits
  • Routinely monitor key performance indicators to make sure auditing processes are running as expected and regularly present KPIs to management
  • Work with purchasing department to maintain and advance supplier evaluation processes
  • Act as QM liaison person for the company’s subsidiaries in the US and Czech Republic and work to align the quality systems of all three locations
  • Provide general assistance to the QM department as needed

 

Project related tasks:

  • Analyze current internal auditing and supplier evaluation processes and suggest/ implement changes to improve effectiveness and compliance to international regulatory requirements
  • Define key performance indicators to routinely monitor the internal und supplier auditing processes

 

Your background:

  • Completed vocational education or University Degree either in a technical field with ample experience in administration or in a non-technical field with a good technical understanding
  • Completed auditor training/ certification or proof of ample practical experience
  • At least 3 years work experience as an internal or supplier auditor in the medical devices industry or as an auditor for a regulatory body
  • Good knowledge and understanding of all relevant regulatory requirements such as ISO 19011, EN ISO 13485, ISO 14971, MDR and preferably of further international requirements such as FDA QSR, JPAL, ANVISA GMP
  • Proficient in both German and English
  • Good writing skills
  • Willingness to travel (ca. 20%)

 

Personal Qualities:

  • “Auditor by heart” with both good technical and excellent interpersonal and communication skills
  • Friendly but persistent personality
  • Very committed employee who works independently and in a structured way and has the ability to prioritize and self-organize even under a heavy workload

 

Our offer:

  • We are a professionally managed family business to which values are important
  • As an international medical technology company we distinguish ourselves through our innovative special products
  • We encourage and challenge you
  • We offer a friendly workplace atmosphere, flexible working hours with core time attendance
  • Professional development and qualification opportunities through numerous training courses
  • Company medical examinations

 

Quality Manager (m/f/d) Audit Specialist

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

Your contact person: Klara Stocklassa (HR Manager)
Please send your application to jobs@osypka.de

or by mail:

OSYPKA AG
Personalabteilung
Earl-H.-Wood-Strasse 1
79618 Rheinfelden-Herten