- P rovide technical guidance to Quality Engineers in review of manufacturing process and product design changes, validation and risk management activities and ensure that design control elements are met at all stages of product development.
- Lead the implementation of company improvement projects, e .g., implementation of electronic Document Control and Training modules in our QMS system from a paper-based system.
- Lead and/or help coordinate regulatory audits and internal audits of Minerva's QMS.
- Provide oversight of Minerva's supplier audit program
- Manage the Corrective and Preventive Action process to guide the organization on the path of continuous improvement. Oversee quality data trending activities. Help prepare and present periodic CAPA Council and Management Review presentations.
- Manage the Document Control system to ensure changes to quality system documents are in accordance with regulations/procedures.
- Provide training in aspects of quality assurance, internal procedures and current Good Manufacturing Practices.
- Write, implement, and/or approve changes to controlled documents (e.g. SOPs, specifications, protocols, reports, manufacturing procedures, etc.) as needed.
- Ensure adherence to internal procedures for cGMP production in accordance with ISO 13485:2016, and FDA QSR .
- Manage QA staff, with oversight for quality assurance responsibilities:
- Ensure timely review and approval of manufacturing batch records, inspection records, nonconformance reports, to facilitate product release and demonstrate compliance to governing regulations and internal procedures.
- Investigate and close customer complaints
- Process NCRs, CAPAs, SCARs, Out of Tolerance Reports, Environmental Excursions, Customer Complaints, Returned Goods Authorization; maintain logs or master lists, and publish/scan approved documents onto company network.
- Ensure employees are trained to current revision documents, and that training records are maintained.
- Process and maintain ECOs, approved documents, and quality records and logs in Document Control.
- Ensure ongoing compliance with external standards and regulations.
- ASQ Certified Quality Engineer.
- ASQ Certified Quality Auditor/Biomedical Auditor
- Understanding of Medical Device Risk management.
- Ability to work well under pressure, to handle multiple projects, and to meet aggressive deadlines.
- Ability to read and understand and implement to compliance regulations, standards and procedures.
- Ability to perform statistical analysis of data.
- Good leadership, analytical and interpersonal skills.
- Exceptional attention to detail and organizational skills.
- Exceptional project management and team building skills.
- Effective verbal and written communication skills.
- Proficient in use of MS Word, MS Excel, PowerPoint is required.
- Proficient use of Visio flowcharting preferred.
- Minimum of a Bachelor's degree, preferably in a scientific or technical field, as well as 10 years direct quality engineering and quality assurance experience within the commercial medical device industry.
- 5 years of Quality Management experience
- Experience in start-up and mid-size company environments.
- Experience with product transfers and integrations from product acquisitions a plus.
- Working knowledge of current ISO 13485:2016, and FDA QSR .
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Sr. Manager, Quality Assurance - Santa Clara, United States - Minerva Surgical Inc
Description
POSITION SUMMARY:
The Sr. QA Manager leads a team of Quality Engineer(s), Document Control Specialist(s), and Quality Assurance Specialists. The Sr.
QA Manager is responsible for overseeing:
material release, batch record review, and finish product release; document control and training; corrective/preventive actions, nonconforming products, complaint investigations; process deviations, rework, design control compliance, risk assessments, supplier audits, internal quality audits, quality records, trending of quality data, and management reviews.
DUTIES & RESPONSIBILITIES:
PREFERRED QUALIFICATIONS:
Preferred Requirements:
Preferred Education and/or Job experience:
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