Miejsce pracy: Szczecin
Design Assurance at Copernicus is an integrated function in product development teams. Design Assurance Specialist works with company Development Team on one or more products, providing insight from Quality and Regulatory perspectives. DASs have the opportunity to participate in discussions and activities throughout the lifecycle of the product, from Ideation to Production. Copernicus is looking for a DAS to join a complex mechanical and electro-mechanical product team. The candidate must be motivated, a quick-learner, and have the ability to work under minimal supervision on projects spanning systems/mechanical/software engineering, quality assurance/control, testing, and manufacturing.
Education & Qualifications:
- Bachelor of Mechanical, Systems, Electrical, Biomedical Engineering or equivalent degree
- Minimum 3 years working in a Design Assurance capacity (or related)
- Knowledge of and experience with the following standards: ISO 13485, ISO 14971
- Experience working in a regulated environment, preferably medical devices
- Comfortable discussing (and interested in) technical (i.e., product-level) requirements
- Experience with compilation and management of regulatory submission files (DHF, DMR, Design Controls)
- Knowledge of and experience with the following standards: IEC 60601-1, IEC 62366, IEC 62304
- Knowledge of software and product lifecycles (concept to release)
- Very confident with written and verbal communication (English)
- Self-motivated and self-managing
- Ability to work in a highly-technical, fast-paced environment
- Ability to communicate clearly and effectively
Duties & Responsibilities:
- Responsible for interpreting and implementing quality system compliance requirements related to design control and production control
- Provide technical expertise in the area of quality assurance to product-specific Engineering, Operations, and other cross-functional team members and personnel
- Plan and participate in risk management activities (e.g., FMEA and Hazard Analysis)
- Plan and participate in verification and validation activities (e.g., participate in system testing)
- Provide guidance on use and application of standards applicable to design projects
- Disposition, coordinate, conduct root cause analysis, and devise solutions for Corrective and Preventive Actions and Non-Conformances
- Participate in technical design reviews, project phase reviews
- Assist with and perform audits for evaluation of supplier compliance with Copernicus and regulatory requirements
- Assist with transfer to manufacturing activities of new and sustaining product lines (knowledge transfer, documentation transfer, etc.)
- Represent QA on new product project teams
- Support creation of regulatory filings as required
- Supervise direct reports, as assigned
- Assist with other tasks as required
- personal development and comprehensive improvement of engineering skills
- high degree of independence in the performance of tasks
- participation in interesting, innovative projects connected to medical devices
- nice and friendly working atmosphere, climate of diligence and reliability
- Multisport card
- group insurance on preferential terms
- participation in integration events.
Please send your completed application documents via mail: firstname.lastname@example.org
Please add consent for processing personal data included: In accordance with the Law of Personal Data Protection of 29.08.1997 (Journal of Laws No. 133, item 883) I give my consent to processing of my personal data contained in the offer for the recruitment process in Copernicus Sp. z o.o.
In accordance with art. 24 sec. 1 of the Act of 29 August 1997 on the Protection of Personal Data (Journal of Laws of 2002, No. 101, item 926, as amended), we inform you that the administrator of personal data provided by you voluntarily to conduct current and future recruitment is Copernicus Sp. z o.o. with headquarters in Szczecin 71-344, at Litewska 10a. You have the right to access, correct and delete your personal data any time.
We will contact selected candidates.