Quality manager okres Michalovce

Quality manager
Michalovce
okres Michalovce, Slovenská republika

Náplň práce, právomoci a zodpovednosti

- 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.

Zamestnanecké výhody a benefity

• 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

Požiadavky na zamestnanca

Úroveň vzdelania

vysokoškolské I. stupňa (bakalárske)

Osobnostné predpoklady a zručnosti

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.