JOB DESCRIPTION- Quality Manager

Division/Department

Quality

Location

2809 W. Walnut Street Johnson City, TN. 37604

Job Title

Quality Manager

Reports to

Senior Quality Assurance and Regulatory Affairs Manager

Type of Position: Full-Time

Hours: 40/week

JOB OVERVIEW (SCOPE)

The position will manage a team of Quality Assurance Specialists and Quality Control Inspectors. The responsibilities include developing plans and introducing recommendations for product and process improvements. They will assist with the efficient and on-time execution of deliverables (eg. complaint handling, internal audits, process validation, internal non-conformities and corrective and preventive actions) to support strategic business growth. This role will also aid in product development and supplier quality evaluations, and to provide quality engineering analysis, support, and problem solving.

The position is responsible for ensuring cohesive maintenance of the QMS within the organization. Maintenance includes revising, developing, and implementing the quality process. Also, they will be ensure medical devices (products) are manufactured to meet or exceed customer expectations and regulatory requirements (including but not limited to: US Food and Drug Administration, Health Canada, European MDD/MDR, Australian Therapeutic Goods Administration, UK Medicines and Healthcare Products Regulatory Agency, and Japan Pharmaceuticals and Medical Device Agency, as required.)

The ideal candidate will be a subject matter expert in the implementation of quality principles related to reliability, product development, process development and test system implementation; a proven self-starter, meticulously detailed and organized, and able to assess projects, drill-down and simplify deliverables, and delegate these items or effectively communicate necessary changes to all levels of the business. This role will be a champion for quality and regulatory compliance in our business.

KEY RESPONSIBILITIES

• Ensures adherence to health and safety guidelines, legal obligations, and maintains accurate documentation.
• Maintains knowledge of relevant quality and regulatory requirements, in coordination with Quality Systems requirements
• Revises site processes to meet changing requirements, including the Medical Device Directive, Medical Device Regulation, US FDA, MDSAP and others, as required
• Provides business impact/statistical analysis of product and process trends to Sr. Management
• Monitors quality process Key Performance Indicators/Metrics, identifies trends, and reports measured metric performance/trend analysis as part of management review
• Take appropriate corrective/preventive actions to ensure product quality, patient safety, compliance with regulatory reporting requirements, and drive process improvements to improve performance
• Implements problem solving methodologies to reduce internal and external defects
• Engages in continuous improvement activities by identifying opportunities and process gaps, recommending improvements to the affected processes, and implementing strategies to improve product and process quality through quality and reliability engineering principles
• Provides ongoing quality engineering insight, guidance, and technical support to operations and engineering throughout the product life cycle, design, and manufacturing changes
• Completes investigations on relevant quality process requirements and standards to ensure alignment with key product design inputs including usability, reliability, performance, quality control planning, ability to manufacture, safety, and effectiveness
• Supports the Materials group and provides quality assessment and input to the supplier evaluation and monitoring process. May include remote or on-site supplier quality audits to ensure supplier is meeting relevant regulatory requirements and standards
• Supports Engineering group by providing review of medical device file, device history records, relevant design verification, validation, and relevant specifications/prints, process validations and selection of appropriate tests and statistically justified sampling sizes based on risk of critical attributes/specifications
• Accountable for timely and compliant execution Quality Assurance team deliverables including, but not limited to:
• Maintenance of related eQMS software
• Product nonconformances and corrective and preventive actions
• Product quality complaints
• Document and record retention
• Risk management
• Internal audit processes
• Accountable for timely and compliant execution of Quality Control team deliverables including but not limited to:
• Validation, maintenance, and calibration of inspection equipment and assurance that inspection equipment and techniques are appropriate
• Incoming/in-process/final inspection material control, acceptance sampling, measurement systems and issuance of release documentation
• Alignment of QC processes and control plans to relevant process validations, outcome of the risk management process, and understanding of customer requirements through solicitation of feedback
• Ensures timely and effective investigation and closure of Quality Assurance and Quality Control NCs and CAPAs
• Ensures timely and effective execution of the internal audit program
• Supports and acts as back-up management representative for external audits
• Participates in special projects and performs other duties as required

Supervision and Management Duties:

• Supervises exempt and non-exempt employees, ensures adequate staffing levels to support operations, provides coaching and feedback for the purpose of professional growth of direct report, and participate in the hiring process
• Assigns and coordinates quality team deliverables to meet business objectives
• Quality team consists of 1-3 quality Assurance Specialists and 4-6 Quality Control Inspectors

Performance Requirements:

• US Endodontics has grown exponentially in the past decade resulting in continuous professional growth opportunities. Typically, to advance to a new job level, position must demonstrate professional behavior and should consistently be at the high-end of meets expectations or consistently exceed expectations

REQUIREMENTS

Skills/Abilities:

• A working knowledge of LEAN and Six Sigma concepts and tools
• Outstanding verbal and written communication skills to all levels of the organization to further improve and maintain site quality culture and understanding of requirements
• Excellent presentation and public speaking skills
• Excellent independent decision-making, analysis, and problem solving skills
• Excellent planning and organizational skills and techniques. Ability to contribute to and lead cross-functional team projects by planning and managing successful projects; understand available resources, develop timeline, budget, assign tasks and areas of responsibility
• Exceptional attention to detail, time management, and organizational skills
• Ability to conduct independent technical research and gather evidence supported data.

Education and Experience:

• Required Experience:
• Supervisory/Management Experience: Minimum of 3 years of experience in a supervisory role OR Minimum of 5 years in cross-functional project management role in a regulated medical device manufacturing environment, or similar industry such as within the aerospace, pharmaceutical, electronics, chemical, automotive, etc.
• Experience in medical devices is highly preferred
• Experience and in-depth working knowledge of ISO 13485 QMS and FDA QSR requirements and related cGXPs such as Good Manufacturing Practices (GMP), Good Documentation Practices (GDP), and Good Laboratory Practices (GLP) are required to successfully perform the role
• Required Education:
• Minimum of 4-year bachelor’s degree in a STEM field (engineering, chemistry, biology, etc.).
• Master’s degree in STEM field or MBA is a plus
• ASQ Certification is a plus

Travel and Physical Requirements:

• Travel – typically not required
• Office environment
• No special physical demands required
• Flexible to work overtime if required

US Endodontics is an Equal Employment Opportunity Employer and does not discriminate against applicants or employees on the basis of race, color, religion, creed, national origin, ancestry, disability that can be reasonably accommodated without undue hardship, sex, sexual orientation, gender identity, age, citizenship, marital or veteran status, or any other legally protected status.

Job Type: Full-time

Pay: $90,000.00 - $120,000.00 per year

Benefits:

• 401(k)
• Dental insurance
• Employee assistance program
• Flexible schedule
• Flexible spending account
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Vision insurance

Schedule:

• Monday to Friday

Experience:

• ISO 13485: 1 year (Required)
• Supervisor/Manager: 3 years (Required)
• Quality management: 3 years (Required)

Work Location: In person