Head of Plant Quality (m/f/d)
- 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