Quality Assurance Specialist
Steripack Medical Poland Sp. z o.o.
- Japońska 1, Jelcz-LaskowiceJelcz-Laskowice, Lower Silesia
- Offer expired a month ago
- contract of employment
- specialist (Mid / Regular)
The Quality Assurance Specialist is responsible for assisting in the implementation and maintenance of an effective Quality System in line with ISO 13485, 21CFR820, GMP.
Responsible for implementing and maintaining the effectiveness of the Quality System.
Independently contribute to Quality System processes which may include training, corrective action and preventive action (CAPA) activities, equipment maintenance, product and process planning, quality audits, validation.
Determine quality attributes and requirements. may provide technical assistance.
Independently utilize quality management techniques to perform investigations and facilitate solutions.
Responsible for independently completing documentation in a timely manner and in accordance with business standards.
Supports required activities for monthly metrics and drive decisions in a timely manner
Ensure work complies with regulatory and compliance standards
Ability to communicate constructively and utilize technical writing skills for quality records
Coordinate/facilitate meetings and/or communicate cross-functionally to develop solid solutions to CAPA activities.
Customer complaints handling.
Manage and coordinate CAPA projects and identify continuous improvement opportunities.
Bachelor’s Degree in a related function or an equivalent combination of education and work experience.
Minimum 3 years of related experience
Demonstrated technical competency and working technical knowledge and application of concepts, practices and procedures
Previous experience in Quality, CAPA, risk management and/or complaints
Previous experience in medical device industry
What we offer
Training and career development,
Financial security through competitive compensation,
Health care program,
The stability of a company with a record of strong financial performance
mobile phone available for private use
no dress code
coffee / tea
parking space for employees
extra social benefits
opportunity to obtain permits and licenses