Head of Plant Quality (m/f/d)

  • Gerresheimer Skopje DOOEL Skopje, Skopje, SK, Mazedonien
  • Full-time

Company Description

Gerresheimer is a leading global partner to the pharma and healthcare industry. Since its foundation in Germany in 1864, the publicly traded company now operates worldwide with 10,000 employees and generates revenue of €1,4 billion. Gerresheimer’s product portfolio includes pharmaceutical packaging and products for the safe and simple administration of medicines, i.e. insulin pens, inhalers, pre-fillable syringes, injection vials, with manufacturing facilities in Asia, Europe and North-and South America.
Gerresheimer will build and establish a new facility in Skopje, North Macedonia as part of the Plastics & Devices Division manufacturing and assembling a variety of precision molded plastic parts for various applications in the medical industry.

Job Description

  • Implementing and maintaining quality levels through enforcement of quality assurance and control processes, procedures and standards, training and reinforcement of expectations, and implementation of corrective actions
  • Building up, leading and developing a local Quality team
  • Identifying and implement opportunities for continuous improvement, cost reductions and equipment maintenance as well as coordination General Management System activities
  • Ensuring compliance with the Gerresheimer MDS Quality System, that is defined by the corporate headquarters (local adoptions has to be aligned with corporate)
  • Certification according to ISO 9001, ISO13485 and ISO15378
  • Managing manpower, equipment and resources of the Quality department
  • Supporting new product development, launching processes and managing QA participation on new production development teams
  • Defining training standards with the Quality team, tracking training records, assuring compliance and being a partner for internal and external audits
  • Ensuring validation and qualification of premises, equipment and processes
  • Managing NCMR, deviations and complaints programs
  • Managing material qualification process and work with purchasing
  • Responsibility for monthly key performance indicators and related reports

Qualifications

  • Minimum of 10 years’ experience in Quality Control or Quality Assurance in a manufacturing facility. Preferable to have injection molding plastic experience or medical device and / or pharmaceutical packaging products experience
  • Bachelor degree or above, preferable to major in Scientific, Engineering or related field, Six Sigma, Black Belt, Green Belt is a plus
  • Macedonian: business fluent (required), English fluent (required), German skills would be an advantage
  • Leaderships skill skills and experience with leading a team of at least seven direct subordinates
  • Experience with lean manufacturing, 21CFR (= Code of Federal Regulations) 820/210/211; ISO 9001:2000, ISO 13485:2003, 2016 and auditing experience
  • Profound knowledge of SPC and SQC applications in a manufacturing environment
  • Expertise in a clean room environment
  • Stable, solid personality with strong leadership skills able to quickly establish credibility internally and externally
  • Strong communication skills both internally and externally utilizing networking and exchanging best practices
  • Possesses intercultural sensitivity and understanding, with the ability to work collaboratively an international business environment
  • Leads by example with a visibly hands-on approach and has a strong ability to train people
  • Excellent planning, project management and organizational skills, with ability to analyze and improve business structures and processes, as well as the ability to effectively communicate goals and objectives to staff
  • Willingness to international business travel within the first month of the employment as onboarding will be mainly in our facilities in Germany for at least three month
  • Employment will be with our company in the Republic of North Macedonia

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