Overview:
As the Director of Quality Assurance for OnPoint Surgical, you will be responsible for leading the quality assurance and quality control functions within our organization. This pivotal role requires strategic thinking, strong leadership, and in-depth knowledge of regulatory requirements governing medical device manufacturing. You will oversee all aspects of quality management, ensuring compliance with industry standards, regulatory requirements, and company policies to uphold product quality and safety, and will be actively involved in day-to-day quality operations, including NCMR’s, CAPAs, post-market activities and supplier controls. This position reports to the CFO. The successful candidate will collaborate closely with cross functional teams to drive continuous improvement initiatives and maintain the highest standards of quality across all processes.
Key Responsibilities:
- Develop and execute the overall quality strategy aligned with organizational goals and regulatory requirements in coordination with the Regulatory Affairs team.
- Provide strategic guidance to senior management on quality related matters, including risk management and compliance.
- Establish and maintain robust electronic quality management systems (QMS) to ensure compliance with ISO 13485, FDA regulations, and other relevant standards.
- Implement and maintain QMS processes, including document control, change management, and corrective/preventive action (CAPA) systems.
- Acquire and maintain a thorough understanding of the subject matter related to the company’s medical devices in order to effectively oversee and directly engage in the creation and review of QMS deliverables.
- Own as well as perform hands-on reviews for Quality Systems processes including Non-Conformance, CAPA, Change Control, Complaint Investigations, Document Control, and Training.
- Develop and manage the internal auditing program to ensure a constant state of compliance. Execute compliance audits of internal operations to ensure compliance with policies, procedures, and regulatory requirements; drive timely completion of associated corrective actions.
- Prepare and lead periodic management reviews.
- Stay abreast of evolving regulations and standards in the medical device industry and ensure that the organization remains in compliance.
- Prepare for and lead interactions with regulatory agencies during inspections and audits, ensuring timely responses and resolution of any findings.
- Support Regulatory Affairs with FDA 510(k) submissions and other key developments.
- Develop and implement quality assurance strategies to monitor and evaluate product quality throughout the product lifecycle.
- Establish, oversee and execute processes for supplier quality management, incoming inspection, and product release in coordination with Operations.
- Direct the activities of the Quality Control team to ensure accurate and timely testing of raw materials, components, and finished products.
- Champion a culture of continuous improvement by identifying opportunities for process optimization, waste reduction, and cost savings.
- Lead cross functional teams to implement quality improvement projects and drive efficiency gains.
- Provide leadership and mentorship to the Quality team, fostering a culture of accountability, collaboration, and professional growth.
- Develop and deliver training programs to ensure that all employees understand and adhere to quality policies and procedures.
Qualifications:
- Bachelor’s degree in engineering, life sciences, or a related field; advanced degree preferred.
- Minimum of 10 years of experience in quality assurance/quality control roles within the medical device industry.
- In-depth knowledge of relevant regulations and standards, including ISO 13485, FDA QSR 820, and MDSAP.
- Proven track record of successfully leading quality management initiatives and driving continuous improvement.
- Strong leadership and communication skills, with the ability to influence and collaborate effectively across all levels of the organization.
- Experience managing regulatory inspections and audits, with a thorough understanding of regulatory requirements and expectations.
- Knowledge and understanding of regulatory and legal frameworks, regulatory requirements, legislation, process, and procedures.
- Certification such as Certified Quality Manager (CQM), Certified Quality Engineer (CQE), or Certified Quality Auditor (CQA) preferred.
This position will be based in Bedford, MA.
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