Quality Manager

Náplň práce, právomoci a zodpovednosti:

About the role:

• Ensure the all task about production are achieved with compliance with QMS system.
• Ensure the right Process FMEA.
• Ensure Master validation plan is prepared based on QMS requirements, ensure process validation will be done by providing statistical guidance including sampling plan.
• Assure links between control plans, process validation and sampling are maintained.
• Support/Ensure Deviation handling, issue Deviations after proper risk evaluation.
• Ensure proper NC handling, NC handling within 45 days.
• Ensure Creation of sorting and reworking procedure including AQL determination and ensure employees are trained properly.
• Lead/Support Investigation of Root Causes of critical or repetitive issues.
• Lead or support CAPA process activities, create or review correction and corrective action plans, Review effectiveness of implemented actions.
• Assess/Approve CAPA records within Global goals.
• Support complaint handling process, complaint reduction initiatives, scrap reduction and process improvements.
• Support/Perform change control process; conduct evaluation and determine impact of implemented changes.
• Lead Stop ship and HHE process – presentation and explanation.
• Supports manufacturing, providing guidance to ensure high quality standards are maintained.
• Supports the implementation of continuous improvement activities by assessing impact on the Quality system and providing guidance on appropriate activities required for implementation.
• Identify areas of opportunity by routine monitoring and data analysis.
• Ensure plant product quality documentation is updated.
• Support implementation of Projects.
• Mentor and coach others in the practical application of procedures, understand the regulatory basis for the procedure and explain the reason behind the regulations.
• Conduct internal audits, use auditing as a proactive tool for improvements as well as assurance of compliance with existing quality requirements.
• Follow up on implementation of audit observation.
• Support external audit readiness activities.

Your key duties and responsibilities:

• Support/Lead solving of serious product quality issues
• Review and Approval of RCI reports
• Assessment/Approval of CAPA records
• Support strategic QA projects
• Approve final decision on serious non-conforming products and components
• Support complaint investigation process
• Evaluate statistical trends and initiate corrective actions
• Approve CCR related to manufacturing process closure if needed
• Continuously monitor production activities for compliance with approved procedures/standards
• Identify areas of improvement / simplification
• Mentor and coach others in the practical application of procedures, understand the regulatory basis for the procedure and explain the reason behind the regulations
• Conduct internal audits, use auditing as a proactive tool for improvements as well as assurance of compliance with existing quality requirements
• Follow up on implementation of audit observation
• Lead external audit readiness of manufacturing areas
• Ensure activities related to production are performed
• Lead multifunctional team, to ensure all team members are qualified and trained so that all activities above are executed and documented following defined requirements
• To ensure compliance with the legislative and internal requirements of the EHS and to participate in the fulfillment of the company's targets in the EHS area
  

Zamestnanecké výhody, benefity:

- Large corporation with representation and manufacturing plants in the world.

- Stable employer for Michalovce city and its surroundings.

- Corporate culture – Underpinning everything we do are our values:

- Improve care

- Deliver results

- Grow together

- Own it

- Do what´s right

- Home office possibilities.

- Flexible working hours.

- Introduction program according to company standards.

- Development trainings.

- Career opportunities for internal employees.

- Referral bonus system.

- Recognition program.

- Meals in the amount of 0.44 Eur per one meal unit / day

- Supplementary pension plan after the trial period with the employer's 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 by vendors within Michalovce city

Informácie o výberovom konaní:
Please send your CV only in English language.

Only candidates who meet our requirements will be invited for the interview. Data of not selected candidates will be deleted in compliance with GDPR and data protection law.
Information about personal data processing of job seekers is located on link: https://www.convatec.com/sk-sk/o-nas/kariera/

Požiadavky na zamestnanca:

Skills & Experience:

• Min. 3 years experience in the Medical Device Industry
• Fluent in English, both verbally and in writing
• Proficiency in MS Office
• Trained in FDA QSR’s, ISO 13485, MDSAP medical device regulations
• Experience as Auditor is welcome
• Experience with quality process
• Leadership, steadfast expertise and working in cross-functional teams

Qualifications/Education:

• BSc or higher degree qualified in Science / Engineering

Travel Requirements:

• The position may involve travel up to 30% of the time.

Working Conditions:

• Office based position with home office possibilities based on the local home office policy.
• Flexible working hours.

Ready to join us?

At Convatec, we’re pioneering trusted medical solutions to improve the lives we touch. If you’re ready to make a real impact, apply today and help us bring our Forever Caring promise to life.

Note: Please send your CV only in English language.