Sr. Manager QA

Sr.

Quality Assurance Manager-Auburn AL

The Senior Quality Assurance Manager reports directly to the Director of Quality.

Summary

We are looking for a forward thinking Senior Quality Assurance Manager that provides leadership of the Quality function to our site in Auburn, AL site.

This key leadership position is accountable for improving product and process quality, compliance and improvements in quality systems, managing customer expectations and creating efficiencies within the quality group to meet business expectations.

The person in this position is also responsible to drive needed changes to meet newly approved regulatory requirements, structure and develop the QA team in support of business growth while creating a culture where everyone take personal ownership for quality.

Qualifications
Bachelor’s Degree in Engineering or Science
10+ years Quality Management experience in a Medical-Device manufacturing company that is certified to ISO 9001:2015 and ISO 13485:2016 and compliant to 21 CFR 820.
Hands-on experience in leading CAPA system and SPC programs.
Moderate computer skills including data-based programs such as MS Excel and MS Access.
Experience with FMEA and other risk management tools
Experience with problem-solving techniques such as PPI, 8D, DMAIC, PPS
Strong, proven leadership, communication, and personnel management skills that inspire and motivate a team.

Must have had experience with formal goal and objectives setting.
Effective written and verbal communication skills in English.
Must have experience working with and managing multiple projects and teams simultaneously
5%-10% travel requirement
MS Office (Word, Excel, Access and PowerPoint) intermediate level.
Use of Statistical software and/or databases.
Preferred
ASQ Quality Engineer or Quality Manager Certified; ASQ lead auditor training 3rd-party training record on ISO 13485 and risk management (ISO 14971)
Experience with MDSAP – Medical Device Single Audit Program
Experience with Lean or Six Sigma improvement systems
Experience in high volume plastics/molding industry.
Responsibilities

Sets the overall quality strategy for the Auburn, AL manufacturing site that supports growth, a perfect customer experience, and compliance to applicable regulatory requirements.

Actively participates in quality improvement projects to move the organization to rely less on inspections and more on quality assurance.
Carries out leadership responsibilities in accordance with the organization’s policies and applicable laws.

Responsibilities include interviewing, hiring, developing and training employees; planning, assigning, and directing work; appraising performance; rewarding, discipline of employees; addressing complaints and resolving problems.
Provides leadership and coaching to Operations Quality, Quality Systems, and Technical Quality/Quality Engineering teams (3
– 5 direct reports; total QA team: 10 -12 employees).
Leads, maintains and creates efficiencies in the Quality Management System to fulfill both domestic and international quality system requirements (e.g.

21 CFR 820, ISO 9001, and FDA Food Safety).
Assures management reviews of the Quality System are held and properly documented to reflect the status of the Quality System effectiveness and resulting corrective actions and improvement plans/actions.
Works closely with all staff to ensure that all aspects of the QMS is understood, implemented and maintained.
Creates cross functional collaboration and influences all business functions to apply appropriate quality tools including Lean, Six Sigma, TQM principles, business process improvement methods and statistical methods (e.g.

design of experiments, statistical process control).
Maintains alliance with Divisional, Group, and corporate Quality and Regulatory Affairs to ensure participation in and understanding of associated initiatives.
Effectively leads Corrective and Preventive Action System.

Works with various departments to identify actions required to assure corrective and preventative actions are properly documented and follows up to initiate and monitor timely completion of actions.
Leads all aspects of the Internal Audit program assuring compliance with regulatory standards.

Coordinate and participate in any external or customer audits.
Sets site wide QA/QC priorities and key objectives to reduce the cost of poor quality and improve the compliance to regulations and the site Quality System.
Leads Key Quality Business Metrics and Department Metrics.
Acts as the site Quality Representative with third party agencies, regulatory agencies and any government agency.
Other duties may be assigned, as required.