Informacje o stanowisku

Job Title: Senior Quality Engineer

About the opportunity: We are seeking a skilled and proactive Senior Quality Engineer to join our Team. In this role, you will lead process risk assessments, support third-party audits, represent Risk Management in the change process, and ensure compliance with international standards and regulations.

Location: Poland, hybrid or remote

What you will be doing:

• Lead process risk management activities as part of the Risk Management team.
• Provide expertise in risk management during change processes.
• Participate in preparation, execution, and follow up activities of third-party audits.
• Take part in external document management to maintain compliance.
• Support process owners to prepare and conduct process risk assessments.
• Collaborate with the Risk Manager to execute the Risk Management strategy for ADC, ensuring alignment with international standards and regulations.

What you need for success:

• Sound knowledge of ISO 13485 AND ISO 14971 is required
• Previous experience with medical devices risk management is required.
• 5-10 years experience in pharmaceutical or medical device industry is required.
• Prior auditing experience is required, preferably with MDSAP
• Fluent English to cooperate with our colleagues in the US is required.
• Experience with leading multifunctional teams
• Familiarity with IEC 62304 and IEC 62366 is an asset
• EU MDR/IVDR and ISO 9001 knowledge is an asset
• Hands-on engineering experience is an asset

What we can offer you:

• Contract of employment, one-time home-office set-up allowance
• Lunch Card - 300 PLN monthly
• Annual bonus
• Life insurance, private medical care – Luxmed VIP package with dental coverage
• Pension Plan (PPE), Employee Assistance Program
• Access to LinkedIn Learning platform with training courses
• Language learning platform online - eTutor

TO ALL RECRUITMENT AGENCIES: Ascensia does not accept unsolicited third-party resumes.

Building an Inclusive Culture: We are a company that brings varying backgrounds, ideas, and points of view to inventing on behalf of all customers. Our diverse perspectives are enriched by many dimensions, including race, ethnicity, gender, age, physical and mental ability, sexual orientation, religious beliefs, culture, language, and education, as well as professional and life experience. We are committed to diversity, equity, and inclusion, and leveraging our unique perspectives to scale our impact and growth.

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