We are currently looking for an experienced Site Quality Assurance Manager for our Warsaw, Indiana facilty. If you have experience leading a Quality Team in the Medical Device Industry, please apply in person or via email to firstname.lastname@example.org .
The Site Quality Assurance Manager will lead and manage the performance of the site’s Quality System and Quality Control processes in achieving all established customer requirements and all applicable regulatory agency requirements. The Site QA Manager will ensure compliance with all established Avalign Corporate Quality System procedures. He/she will collaborate with customers to establish product quality requirements and develop customer compliance strategies. The Site QA Manager acts as a liaison between the company and various governmental agencies and notified bodies to assure compliance to all quality and regulatory standards.
Essential Duties and Responsibilities
· Provides vision and leadership for quality for the site by determining quality objectives and linking those objectives to company and corporate objectives
· Develops, establishes and maintains quality assurance programs, policies, processes, procedures and controls ensuring that performance and quality of products conform to established company, international (ISO), and governmental regulatory standards and agency guidelines, and to ensure customer satisfaction
· Manages projects in support of new business development for the site
· Develops, implements, and maintains Quality Engineering principles and practices for the site
· Acts as the Quality Systems Management Representative for the site
· Maintains compliance and effectiveness to Quality Management System
· Represents the business/site to outside regulatory bodies
· Provides expertise and guidance in interpreting governmental regulations, agency guidelines and internal policies to assure compliance and drives implementation for the site
· Manages quality assurance efforts and is responsible for all regulatory compliance issues
· Develops and directs quality programs involving methods, devices and controls
· Maintains quality through internal and external inspection of raw materials and finished items purchased and production operations and processes
· Determines and establishes assigned quality organizational structure and supervisory relationships. Coaches, develops and mentors employees in work group.
· Collaborates with cross-functional colleagues to ensure achievement of standards and regulations
The Site QA Manager is responsible for the overall direction, coordination, and evaluation of quality employees for the worksite. He/she carries out supervisory responsibilities in accordance with the organization's policies and applicable laws. Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.
To perform the job successfully, an individual should demonstrate the following competencies:
· Management - Manage inspection measurement and gaging practices established for manufacturing CNC machined components used for medical devices.
· Design - Designs work flows and procedures; generates creative solutions; translates concepts and information into images; uses feedback to modify designs; applies design principles and demonstrates attention to detail.
· Project Management – Ability to lead quality project management and present problem resolution
· Communication Skills - Ability to listen effectively and utilize various modes to communicate with employees at all levels.
· Initiative- Sets and achieves challenging goals and is persistent to overcome obstacles.
· Professionalism - Treats others with respect and consideration regardless of their status or position; Accepts responsibility for own actions and follows through on commitments.
· Quality - Demonstrates accuracy and thoroughness to improve and promote quality; Applies feedback to improve performance; and monitors own work to ensure quality.
Qualifications (Education, Certifications and/or Experience)
· Education: BS degree in science or engineering from an accredited college.
· Experience: Minimum 5 years experience in Quality Assurance in a Medical Device manufacturing environment, of which at least 3 years experience in a quality management position. Management of inspection measurement and gaging practices established for manufacturing CNC machined components used for medical devices.
· Skils: Strong written and oral communication skills. Good knowledge of computers and standard office software. Strong, working knowledge of current FDA QSR and ISO 13485 requirements for Medical Device manufacturing. Strong interpersonal skills, with the ability to work effectively in a team or lead a team. High ethical standards.
· Prolonged standing, sitting and/or walking.
· Medium Work: Exerting up to 50 lbs. of force occasionally to move objects.
· Near Acuity: Normal with corrective lenses.
· Adaptability to situations requiring the precise attainment of set standards.