Senior Quality Systems Engineer - Waltham, United States - Paragonix Technologies, Inc.
Description
Paragonix Technologies markets organ transportation devices that safeguard organs during the journey between donor and recipient patients. Our devices incorporate clinically proven and medically trusted cold preservation techniques in a novel suspension system to provide unprecedented physical and thermal protection. Our product portfolio spans cardiac, thoracic, and abdominal preservation devices to improve donor organ quality and extend donor organ transport time.
Position Overview: As a Senior Quality Systems Engineer, you will play a crucial role in ensuring the highest standards of quality throughout our organization. This position requires a strategic thinker with a deep understanding of quality management systems, change control processes, and a proven track record of implementing and maintaining robust quality processes.
Responsibilities
1.Quality Management System (QMS) Leadership:
Lead the development, implementation, and maintenance of the company's QMS in accordance with relevant industry standards and regulations.
Analyzing quality data and generating reports to assess the performance of the quality management system and identify trends or areas for improvement.
2.Change Control:
Implement, manage, and drive continuous improvement in change control processes to ensure that changes to products, processes, or systems are documented, reviewed, and approved in accordance with established procedures.
Collaborate with cross-functional teams to assess the impact of proposed changes and ensure compliance with regulatory requirements.
3.Audits and Inspections:
Plan, coordinate, and conduct internal and external audits to assess compliance with QMS requirements.
Prepare for and support regulatory inspections, ensuring a state of readiness.
4.Training and Development:
Provide training and guidance to employees on quality systems, change control procedures, and related processes.
Foster a culture of quality throughout the organization through education and awareness initiatives.
5.Supplier Management:
Collaborate with cross-functional teams to evaluate and qualify new suppliers.
Manage the supplier audit process to assess and ensure the compliance of suppliers with established quality standards.
Establishing key performance indicators (KPIs) to measure supplier performance.
Maintaining accurate records of supplier assessments, approved supplier list, audits, and performance evaluations
6.Documentation and Record Management:
Oversee the creation, review, and maintenance of quality documentation and records.
Ensure documentation complies with regulatory standards and internal requirements.
7.CAPA
Manage the Corrective and Preventive Actions (CAPA) program for compliance to internal procedures, ensuring timely resolution of planned activities.
Collaborate with teams to investigate and resolve quality issues, implement corrective actions to prevent recurrence, and verify effectiveness of actions.
8.Process Improvement:
Identify opportunities for continuous improvement in quality processes and lead initiatives to enhance efficiency and effectiveness.
Implement Lean and Six Sigma methodologies to streamline processes and reduce nonconformities.
Qualifications
Bachelor's degree in engineering or scientific discipline; Master's degree is a plus.
Minimum 3 years of experience in a quality systems role, with a focus on the medical device industry.
In-depth knowledge of relevant quality standards and regulations, including ISO 13485, ISO 9001, and 21 CFR 820.
Proven experience in leading and implementing QMS processes, change control initiatives, and CAPA programs in a regulated environment.
Strong familiarity with risk management methodologies and their integration into quality processes.
Experience in conducting internal and external audits, with a preference for those holding certifications as lead auditors.
Demonstrated success in collaborating with cross-functional teams to drive continuous improvement in quality systems and processes.
Exceptional analytical and problem-solving skills, with a keen attention to detail.
Excellent communication and interpersonal skills, with the ability to effectively convey complex quality concepts to diverse audiences.
Familiarity with statistical methods and tools for data analysis.
Ability to stay abreast of changes in industry regulations and standards, ensuring ongoing compliance.
Proven track record of successful supplier management, including the qualification and oversight of suppliers in a regulated environment.
Strong leadership skills with the ability to inspire and mentor a team focused on achieving and maintaining high-quality standards.
Preference will be given to candidates with certifications as Lead Auditors (e.g., ISO 13485 Lead Auditor, ASQ Certified Quality Auditor).
Excellent oral and written communication skills in English.
Able to travel domestically and internationally as required (