Design Controller
3 weeks ago
We are seeking a highly skilled Design Controller to join our team at GN Store Nord A/S. As a key member of our R&D Hearing team in Poland, you will play a critical role in ensuring the quality and compliance of our medical device software projects.
Key Responsibilities- Plan and Coordinate Software Development Deliverables: Collaborate with cross-functional teams to ensure timely completion of software development projects in compliance with corporate QMS and regulatory standards.
- Facilitate Design Reviews and Risk Assessments: Participate in design reviews and risk assessments to ensure compliance with regulatory requirements and identify areas for improvement.
- Streamline Compliance Documentation: Work with Corporate Quality and internal stakeholders to optimize and improve compliance documentation, reducing administrative burdens and ensuring seamless processes.
- Oversee Audit Processes: Lead audit processes, including findings from GN Online Services and Fitting Software, to ensure compliance and identify areas for improvement.
- Improve Design Control Process: Continuously evaluate and improve the Design Control process to ensure it remains effective and efficient.
- 5+ Years in Medical Device Industry: Proven experience in the medical device industry, with a strong understanding of regulatory requirements and industry standards.
- Proficiency in English: Excellent written and verbal communication skills in English, with the ability to communicate effectively across cultures and levels of the organization.
- Solid Understanding of Medical Device Design Control and Regulations: In-depth knowledge of medical device design control and regulations, including 21 CFR 820.30, ISO 13485, ISO 14971, IEC 62304, and IEC 62366.
- Demonstrated Initiative and Results-Oriented: Proven ability to take initiative, drive results, and implement change in a fast-paced environment.
- Ability to Communicate Effectively: Excellent verbal and written communication skills, with the ability to communicate effectively in a multi-discipline environment.
- BS in Engineering or Sciences: Bachelor's degree in engineering or sciences, with a strong foundation in technical principles and practices.
GN Store Nord A/S is a leading provider of intelligent hearing, audio, video, and gaming solutions. We are committed to bringing people closer through our innovative products and services. Our company values include listening, challenging, and transforming, and we strive to create a culture of energy, engagement, and enthusiasm.
We offer a range of benefits and flexibility to support our employees' well-being and career development. If you are a motivated and results-driven individual with a passion for medical device design control, we encourage you to apply for this exciting opportunity.
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