2250 € / month The basic salary amount is negotiable, individually.
Job description
- Ensure the correct Process FMEA is conducted and that the Master Validation Plan based on QMS requirements.
- Provide statistical guidance, including sampling plans, for process validation.
- Maintain links between control plans, process validation, and sampling.
- Proper and careful risk evaluation.
- Ensure proper handling of non-conformances (NC), with NCs addressed within 45 days.
- Create sorting and reworking procedures, including AQL determination, and ensure employees are properly trained.
- Lead or support investigations into the root causes of critical or repetitive issues
- Lead or support CAPA process activities
- Support the complaint handling process, complaint reduction initiatives, scrap reduction, and process improvements.
- Support or perform the change control process; evaluate and determine the impact of implemented changes.
- Lead the Stop Ship and HHE process, including presentation and explanation.
- Provide guidance to manufacturing to ensure high-quality standards are maintained.
- Support the implementation of continuous improvement activities by assessing their impact on the Quality System and providing guidance on necessary actions.
- Identify areas of opportunity through routine monitoring and data analysis.
- Ensure plant product quality documentation is updated and support project implementation.
- Mentor and coach others in the practical application of procedures, explaining the regulatory basis and reasoning behind the regulations.
- Conduct internal audits, using them as proactive tools for improvement and ensuring compliance with quality requirements.
- Follow up on audit observations and support external audit readiness activities.
Employee perks, benefits
• Hybrid work possibilities.
• Flexible working hours.
• Introduction program according to company standards.
• Development trainings.
• Career opportunities for internal employees.
• Referral bonuses.
• Recognition program.
• Meals in the amount of 0.17 Eur per one meal unit / day.
• Supplementary pension plan after the trial period with the employers contribution.
• Social fund (various support and perks for employees).
• Free bus transport within Michalovce city.
• Various events / team building activities for employees.
• Various employee discounts
Employee requirements
Education
University education (Bachelor's degree) University education (Master's degree)
Specialisation, field
technical fields
Language and language level
English
Number of years of experience
3
Experience in the position/sector
process quality
Personality requirements and skills
Min. 3 years’ experience in the Medical Device Industry – Preferred.
Fluent in English, both verbally and in writing.
Proficiency in MS Office.
Trained in FDA QSR’s, ISO 13485, MDSAP medical device regulations – Preferred.
Experience as Auditor is an advantage.
Experience with quality processes.
Leadership, steadfast expertise and working in cross-functional teams.
Information about the selection process
The number of job openings
1
Date of completion of the selection process
2024-12-01
Information for the job seeker
If you are good match to requirements, please send your CV! We are contacting you, immediately.
If you send your CV by e-mail, please, add the following text (below) to the CV. Otherwise, your application will not be possible to process further.
By responding to the job offer, in accordance with General Data Protection Regulation 2016/679 (hereinafter "GDPR"), I declare that I have read and understood the content of the document "Personal Data Processing Notice", which is available at https://praca.manpower.sk/ochrana-osobnych-udajov/?lang=en, and, I hereby acknowledge that:
i) my personal data will be processed by ManpowerGroup Slovensko sro, with its registered office at Landererova 12, 811 09 Bratislava, Slovak Republic, IČO: 35958898, registered in the Commercial Register of OS Bratislava I, section: Sro, file number: 37879 / B (hereinafter referred to as "the Data Controller"), In full compliance with the GDPR Regulation and other applicable legislation, in the manner and to the extent set out in the "Personal Data Processing Notice";
ii) if, as a data owner, I request more information about the processing of my personal data or I want to exercise my individual rights, I can contact the Data Controller either through the contact details provided in the "Personal Data Processing Notice" or through the online form "Submission of data subject request"
How to contact us
If you have any questions or comments about this "Privacy Notice" or wish to exercise your individual rights, you can contact us in writing either at the registered office of ManpowerGroup Slovensko sro, Landererova 12, 811 09 Bratislava, Slovak Republic, or via the online form. "Submission of data subject request", which can be found here.
