Job Description

Position Overview:

The Manager of Quality will lead the Quality Engineering and Incoming QC team associated with medical product design and manufacturing at Bolt Medical. The manager will be responsible for ensuring internal compliance to the Bolt Medical Quality Management System and will ensure overall Quality Management System compliance with applicable regulatory requirements, including but not limited to 21 CFR 820, EN ISO 13485:2016, EN 14971:2019, and all other applicable regulations and requirements.

Responsibilities:

• Develop and implement policies and procedures to assure Bolt Medical’s quality management system complies with all applicable U.S. and foreign regulatory standards and guidance documents.
• Managing Quality Control functions related to Operations for disposable products, including receiving inspection, in-process inspection, final inspection, product release activities, NCR, quality engineering, clean room monitoring, and disposables supplier quality.
• Managing metrology and calibration activities
• Lead initiatives to ensure effective quality reporting, quality systems and quality improvement efforts.
• Aggressively identify and manage activities related to adding value to the organization through risk reduction, cost improvement, and budgetary responsibility
• Providing organizational leadership, coaching, mentoring, and guidance to all Quality personnel as well as cross-functional teams
• Acting as a site champion for Quality Best Practices and cGMP within the organization
• Initiating and/or collaborating in the generation/update of process/product Risk Management documentation (e.g., FMEAs and Hazard Analysis) with cross-functional engineering teams
• Responsible for building the Quality Engineering organization for disposables as Bolt Medical matures and grows.
• Contributes to overall Quality Assurance success by providing expertise in relevant Quality Systems development, and in audits.
• Establishes operational objectives and work plans, and delegates assignments to team members and supporting employees.
• Provides guidance and support to team members.
• Occasionally interacts with senior management or executive levels on matters concerning functional area.
• Requires the ability to effectively influence others and manage sensitive situations.
• Directly manages the coordination of the activities within Quality Assurance with responsibility for results, including costs, methods, and staffing.
• People management responsibilities include performance reviews and compensation decisions.
• Is responsible for compliance with quality system procedures and all regulatory requirements.
• Consistently promotes collaboration, positivity, accountability, and resourcefulness.
• Must demonstrate mutual respect, ongoing communication, and a positive outlook with both internal team members and customers.

Qualifications:

• Education: Requires a Bachelor's and/or Master's degree or equivalent combination of education and experience.

• Required Experience: 15 years of medical device experience
• 5 years of quality management related experience
• Experience in catheter design and production, or with similar medical devices, while working within Quality is required.

• Knowledge, Skills, and Abilities: Demonstrated experience in Design Controls and Risk Analysis.
• Demonstrated expertise in Process Validation, Product Validation, and Statistical Methods.
• Demonstrated expertise in product sterilization biocompatibility, and clean room requirements
• Applied understanding of 21 CFR 820, EN ISO 13485:2016, ISO 14971:2019
• Knowledge and awareness spans all aspects of the specific functional area.
• Enhances understanding and knowledge of how functional objectives support corporate objectives
• Must be able to understand job duties and responsibilities, have the necessary skills/knowledge and be willing and able to continue learning and growing within the field.
• Must be skilled at managing a significant workload and obtaining positive results, taking on additional responsibility and managing priorities as needed.
• Must be accurate, detailed, committed to high quality standards and pro-active in finding solutions to achieve successful outcomes.
• Strong verbal and written communication skills with the ability to produce accurate, punctual reports/information, as required and thoroughly share information with others.
• Must be able to read, write and speak effectively.
• Exceptional listening skills with the ability to seek constructive feedback, build relationships, promote teamwork, and remain flexible and open-minded. Able to quickly adapt to change.
• Capable of following realistic plans, goal setting, resource management, contingency planning, coordinating, and cooperating with others.
• Capable of working thoughtfully under pressure and in a timely manner.

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