Kraków/ Hybrid 16.000 - 18.000 PLN

Our Partner is a leading company specializing in the production of medical implants, dedicated to improving the quality of life for patients worldwide. Their commitment to innovation and excellence has established us as a prominent player in the medical device industry. We are seeking a detail-oriented and organized Supplier Quality Engineer to manage and coordinate supplier changes in processes, equipment, line transfers, and material sourcing. This role is crucial in defining PPAP (Production Part Approval Process) requirements, preparing draft PPAP, coordinating with suppliers for evidence and regulatory/FDA requirements, and reviewing various PPAP documents received from suppliers.

Healthcare Supplier Quality Engineer

• Review changes requested by suppliers for process changes, equipment changes, line transfers, and material sourcing changes,

• Define PPAP requirements and other site-specific requirements for the change.

• Prepare draft PPAP and coordinate with suppliers for the evidence and regulatory/FDA requirements,

• Review various PPAP documents received from suppliers (PFD, PFMEA, PCP, Validation documents, Process capability study reports, etc.) and validate against the process or part requirements,

• Review process validation plans, protocols, and reports associated with Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ),

• Coordinate with internal stakeholders/SME’s to obtain approval and route it to respective stakeholders,

• Work with sterility assessment, bio burden SME’s to close as per site requirement based on the type of change,

• Coordinate with change analysts to close the ECN/ECR’s after appropriate approval,

• Communicate with SICR owners & site SPOCs on the status of each SICR and ETA.

• Bachelor's or Master's degree in Engineering,

• Minimum 3-years’ experience in supplier quality engineering or related field,

• Fluency in English,

• Any experience with medical devices or healthcare industry will be a strong asset,

• General experience in the healthcare industry (preferred),

• Strong knowledge of PPAP requirements and documents,

• Experience in reviewing process validation plans, protocols, and reports,

• Strong analytical and problem-solving skills,

• Excellent communication and coordination skills,

• Knowledge of regulatory/FDA requirements,

• ISO 13485 familiarity a plus. 

• Your salary will be highly correlated with your skills and mindset: from 16.000 up to 18.000+ gross PLN,

• Participating it the newest technology solutions, classified products and services,

• A company culture based on autonomy, high-trust & accountability,

• Full – time permanent contract of employment,

• PPK – employee pension program,

• Lux Med – private medical care for employees and family members,

• Exciting and Challenging Projects,

• Collaborative and Dynamic Environment,

• Being part of an ambitious company with a lot of growth opportunities awarded with Great Place to Work® 2023,

• Playing a crucial role in the development team,

• Waking up in the morning knowing you are making a difference,

• Working in an agile culture with exposure to international environment,

• Hot & cold beverages,

• Fruits & snacks,

• Shower & bike parking,

• Chill room and playroom for children,

• Integration events.

Recruitment process steps:

• Send your CV via H4H form or email: biuro@h4h.com.pl

• A 10-20 minutes phone call with H4H IT Consultant to enrich your application with missing details.

• A 15-30 minutes video call with our Partner’s Tech Leader, to evaluate your skills. We may redo it whether we have some better job offers for you.

• A 15-30 minutes video call with end Client representatives - automotive component manufacturing company to ensure good understanding of the role for your side and enable you to ask any questions regarding your new role.

• A short video-call or phone call with our Partner’s HR Business Partner to check in depth the alignment between you and values and culture of the Company. Financial negotiations are welcomed :)

• Welcome aboard!

About our recruitment process:

Our recruitment process is tailored to do our best to avoid that you or we realize that we’re not a perfect fit in two or six months. It might seem long, but every step serves a purpose and will allow us to get to know you better as much as it’ll help you understand more where you’ll be stepping in.

We also want you to have time to ask all your questions regarding your job description, the long-term vision of your team and the company, our values, with the relevant interlocutor in front of you.

The steps mentioned above can be rearranged depending on yours and the interviewer’s availability.

How to nail your application:

• Tailor your CV & application to our specific job description and company. Attention to detail is important as an employee as it is as an applicant!

• Complete the different steps of the application process in a timely manner, to ensure you don’t miss out on this opportunity!

• Help us synchronize your availability with our Managers’ calendars to fulfil the video calls.

• Prepare your interviews and the questions you will ask at each step, depending on who’s conducting it.

• Any copy-pasted or non-personalized application will not be considered. Non-UE citizens will not be considered due to project requirements.

Direct contact to our TA Specialist:

Albert: tel.: +48 730 922 375, a.welk@h4h.com.pl