Place of work:
Michalovce

Salary:
from 1800EUR/month (The final salary depends on the amount of experience)

Contract type:
full-time

Start date:
ASAP

About the role:

As a Senior Engineer – Business Quality (Senior Quality Compliance Engineer) you will be responsible of maintaining high quality standards for the product manufacturing and compliance with all applicable regulatory requirements. The scope is focused on Quality Compliance processes and is assured via the execution of the Corporate Quality Compliance Programs.

Job Description

Internal Audit Process:

• Execute the Internal Audit Process in the organization according to the site schedule
• The position provides leadership, oversight, and strategic guidance for site issues related to Quality Compliance
• Ensure that the Quality Management System is periodically evaluated and audited and appropriate CAPA is taken to meet the business and regulatory requirements
• Ensure robust investigation of Audit Observations and adequate CAPA action plans, ensure alignment in Audit Non Conformance Ratings
• Liaise with Site Leaders on assessing gaps and defining actions plans related to Internal Audit Non Conformances
• Analyse Internal Audit data for systemic trends, drive compliance and improvement in Internal Audit Metrics
• Gather and analyse data as an input to the Management Reviews to allow meaningful review
• Support Internal Audit and Corporate Audits as required

External Audit Process:

• External audit process execution, from readiness, to execution, response and tracking of commitments
• Provides leadership, oversight, and strategic guidance for companywide issues related to Quality compliance
• Liaise with Quality Leaders on assessing gaps and defining actions plans related to External Audit Non-Conformances, reviewing and approving responses to Notified Body/Health Authorities as applicable
• Gather and analyse data as an input to the Management Reviews and/or CAPA Review Board

Compliance and Education Program:

• Contribute to the development of Corporate training materials to execute the Internal Audit Program and compliance education trainings (QSR, ISO, GMPs)
• Coach/train internal auditors
• Keep abreast of all current regulatory and statutory expectations
• Support Regulation/Standard Gap Assessments and implementation as required

Inspection readiness:

• Enable successful product realization and compliance through readiness compliance activities, assessments, and other consultation
• Ensure sites are in permanent state of inspection readiness using readiness tools
• Support coordination of responses to Notified Bodies to ensure SME and Management engagement and buy-in
• Performs and lead Gemba walks as part of readiness activities

Health Authority:

• Support External Audits and responses

Other responsibilities:

• Support other projects as required by the business

About you:

• Internal Lead Auditor Certification and experience in executing audits
• Excellent written and verbal communication skills, with an open, collaborative, interactive leadership style
• Ability to build and nurture strong and positive relationships with other leaders to partner effectively
• Balanced technical understanding of products and processes combined with business and compliance acumen

Education / Qualifications:

• Minimum of B.S., or equivalent, in a scientific/technical discipline is required
• Five to Ten (5-10) years in the medical device and/or pharmaceutical industry preferred. We welcome candidates also from other regulated industries
• Two to Four (2-4) years’ experience in a QA/QC role
• Practical experience and global mastery in global quality standards and regulations governing medical products.
• Communicative level of English language

Contact:

astell@astell.sk