The organization is looking for a reliable Quality Assurance Manager to ensure that all external and internal requirements are met before the product reaches patients and customers.
The candidate will be responsible for implementing the Quality System as per ISO 13485, obtaining certification, managing the quality relationship with the contract manufacturer, and taking part in activities related to design control, manufacturing, and distribution of an innovative medical device comprised of hardware and software.
The company is in the development stage and requires an individual with solid experience in implementing a Quality System under tight deadlines. The ideal candidate is a reliable and competent professional who can lead design control activities while ensuring compliance during our clinical phase. Ultimately, the chosen candidate will ensure the company is ready for certification, regulatory filings, and commercialization.
The goal is to ensure the high quality of our operations and services aiming to the long-term success of our business.
- Implement a quality system compliant with ISO 13485, FDA 21 CFR Part 820, MDR 2017/745/EU
- Execute and guide teams through Design Control requirements
- Lead the certification process with chosen registrar
- Support transfer to manufacturing
- Manage quality-related projects with contract manufacturer
- Support preclinical and clinical planning and readiness
- Support Regulatory submissions
- Manage the risk management plan, risk file, and risk report with the help of the Product team
- Support audits, both internal and external Support SOP creation and maintenance
- Monitor all operations that affect quality, including NCRs/CAPAs
- Facilitate proactive solutions by collecting and analyzing quality data Assist in ensuring applicability of current quality policies, procedures and objectives by keeping informed of the latest updates/modifications related to applicable regulations (ISO, Ministries of Health (FDA, EMA, Health Canada, etc.))
- Provide support to other regulatory staff as needed and perform duties and assignments as required.
- Communicate and raise questions/issues to the attention of regulatory management
Requirements and skills
- Proven experience as a quality assurance manager or relevant role
- Thorough knowledge of methodologies of quality assurance and standards
- Demonstrated skills in risk management (ISO 14971) and documentation compliant with standards and guidelines of the medical device industry (e.g., technical documentation, design history file)
- Experience and/or specialization in one or more of the following areas:
- Active medical devices – ISO 14708 series
- Medical electrical devices – IEC 60601 series
- Software as a Medical Device - IEC 62304
- Medical device usability engineering - IEC 62366
Excellent numerical skills and understanding of data analysis/statistical methods Good knowledge of MS Office and databases Possess a positive, “can-do” attitude Strong at taking initiative, fast learner Great attention to detail and a results driven approach Excellent organizational and leadership abilities Fluency in written and oral English