Quality Manager

Standex•Summerville, SC

29d

About The Position

Standex International is a global industrial growth company operating through our market-leading brands in electronics, cutting-edge forming technologies, engraving, and scientific refrigeration. We work with our customers to advance progress through innovation. From inventing and producing parts for next-generation space vehicles to evolving vaccine refrigeration, designing functional textures for everyday products, improving renewable energy technology, and much more, we are focused on making what’s next possible. The Quality Manager is responsible for the leadership and oversight of the Quality Management System which will consist of the following quality system elements: Quality System Management Review (QSMR), CAPA system management, Quality Planning, Quality Metrics, Intracompany Quality Agreement Management, External Standard Management, and Training.

Requirements

Bachelor of Art or Science Degree, preferred degree in Engineering, Life Sciences, or Physical Sciences
5 Years experience in medical device, pharmaceutical, or other regulated industry is required
3 Years experience in quality assurance in regulated industry; Medical Device is preferred
2 Years experience in management is preferred
Knowledge of 21 CFR 820, ISO 13485, MDSAP, MDD/ EU MDR
Experience in quality systems within medical device or pharmaceutical industry
Experience in training, management reviews, and QS metrics
Experience leading regulatory inspections and audits (i.e. FDA or Notified Body)
Experience in Microsoft Office (i.e. Word, Excel, PowerPoint)
Ability to work in a self-directed environment and team environment
Ability to influence across functional areas and make change
Skilled project manager and change management
Critical thinker, detailed oriented, organized, and collaborative
Excellent written and oral communication skills
Strong leadership and coaching skills

Responsibilities

Provide daily leadership and management for the Quality System team.
Establish, maintain, and improve the Quality System procedures and processes.
Serve as Management Representative in accordance with 21 CFR 820.20
Act as QS subject matter expert and resource leader for Quality Assurance to deliver results.
Work in a cross-functional environment to identify process and system improvements to enhance efficiency and improve process performance while maintaining compliance.
Lead, influence, and negotiate to achieve business strategies and deliver results on time.
Develop and implement measures and metrics to monitor QS and present to executive management.
Lead Quality System Management Reviews to ensure QS is suitable, adequate, and effective.
Provide leadership and oversight of the CAPA system and sub-processes.
Establish, maintain and implement Quality System training to the entire organization including a system to maintain training records.
Develop annual quality plans and objectives and ensure commitments are met and effective.
Serve as technical expert of QS, Management Controls for the organization.
Represent the company by hosting Quality System audits conducted by external parties, including regulatory inspections.
Provide inspection support: inspection readiness, execution (front room and back room), and post inspection activities.
Other duties as assigned.