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Product Quality Engineer
Unomedical s.r.o.
Priemyselný park 3, Michalovce
full-time
by agreement
1 450 EUR/monthminimum 1450€ / monthly (depending on experiences and quality of the candidate) + quarterly bonus and other benefits in compliance with social benefit program of the company.
Information about the position
Job description, responsibilities and duties
Every day, our products improve the lives of millions of people around the world. We’re hugely proud of this, which is why we’re transforming our business to reach millions more. Join us on our journey to #ForeverCaring as a Product Quality Engineer, and you’ll drive progress that really means something.
About the role:
Effectively uses Scientific / Engineering knowledge and training combined with Quality Systems / Regulatory, Clinical and GXP Requirements knowledge to support Manufacturing of Medical Devices and the development of existing Products within Design Control process.
The role ensures compliance with Corporate Quality System procedures during Process Development, Design Transfer, Process Validation, Launch and Engineering Change activities. Collaborates with internal suppliers and customers to establish product quality requirements.
Your key duties and responsibilities as a Product Quality Engineer:
Responsible for ensuring that Design Control requirements meet regulatory and applicable procedural requirements
Responsible for reviewing and approving design control document outputs
Works closely with R&D and Manufacturing QE’s, regulatory affairs, as well as post-market activities, & colleagues
Uses technical and GXP knowledge to influence and assure Quality and Compliance in Design and develops plans for Post Launch / lifecycle management activities
Provides leadership as subject expert in Risk Management activities and assists Design Control and actively supports and influences R&D teams in the translation of User Needs to Design
Responsible for Post Launch Reviews as appropriate
Investigates product / process performance issues and leads or participates in multifunctional evaluation of products in the market
Evaluates data using statistical tools
Leads or support Complaint investigations through Root Cause Analysis and effective Corrective or Preventive Actions (CAPA)
Leads or actively supports Product Change Control
Collates and shares information / data through reports and follows up on identified improvement opportunities
Actively participates and / or drives site / Company wide Quality System improvements as required
Responsible for FMEA (PFMEA, DFMEA, UFMEA) & Hazard analysis – autor, reviewer, approver
HHE – responsible, participates
Employee perks, benefits
- Quarterly bonus after the trial period - max. 10% from the monthly salary of the employee (based on the results of the production plant).
- 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.
Information about the selection process
Information about personal data processing of job seekers is located on link: https://www.convatec.com/sk-sk/o-nas/kariera/
Requirements for the employee
Candidates with education suit the position
University education (Master's degree)
Educational Specialization
Language skills
Personality requirements and skills
About you:
Experience gained within a Regulated Industry, preferable Medical Devices
Demonstrated knowledge of Regulatory and GXP Compliance requirements such as QSR Part 820, MDD 93/42, GMP Parts 210 and 211, ISO 9001 / ISO 13485. Good knowledge of Design Controls
Demonstrated knowledge and experience of Risk Management and the application and use of Risk Management Tools such as FMEA, Process Mapping, Hazard Analysis. ISO 14971
Experience with Quality tools such as Quality Control Plans, Test Method validation and transfer, Statistics, Experimental Designs, Root Cause Analysis, Process validation, Process Optimization
Logical Thinking Skills and Experience: demonstrated ability to analyze and interpret complex problems / data gathered from a variety of sources and utilize
Demonstrated ability to effectively work and communicate in a cross-function, multinational environment building co-operative working relationships. Demonstrated ability to work effectively with multi-cultural and diverse suppliers and contract manufacturers
Good interpersonal skills and ability to influence people without direct authority
Proactive and flexible in adapting to changing environment and able to manage and prioritize work and competing objectives
Statistical knowledge, experience is desirable
Six Sigma knowledge, experience and certification is desirable
Experience of plastics, extrusion, injection moulding, assembly, bonding
Education / Qualifications:
Degree (or equivalent) in Science or Engineering
Membership of a professional institution is desirable
Degree or proven experience in science / engineering
Must be proficient with PC programs, i.e. Excel, Word, and PowerPoint. Statistical tools (e.g. Minitab) and MS Project and SAP knowledge desirable
Our products make a big difference every day. So will your contribution. The work you do will mean more, because it’ll make things better for your team, our business or our customers’ lives.
It’ll inspire you to deliver to your very best. And we’ll be right behind you when you do.
This is a challenge more worthwhile.
This is work that’ll move you.
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Brief description of the company
To find out more please visit https://careers.convatec.com - thanks for your interest!