The posting
SUMMARY Oversee and manage quality organization and regulatory affairs activities within the department, including quality engineering, compliance, metrology/inspection, document control, and regulatory affairs as well as complete oversight of the quality management system of the entire manufacturing campus. Implements and maintains overall quality department objectives and initiatives to meet corporate and customer requirements. Address complex project problems, incorporates risk management tools, and works with manufacturing managers, engineering managers, and facility leadership to develop data driven solutions to achieve productivity, quality, customer satisfaction goals and objectives. ESSENTIAL JOB FUNCTIONS
All Quality Management Representative responsibilities, commitment, and planning established in applicable global regulations. Maintains high understanding of requirements from customers and regulators. Leads site in application of risk-based management especially as it pertains to change management, complaint investigations, nonconforming materials, CAPA and maintaining business continuity. Develop and coordinate regulatory plans with full implementation of new, transfer, legacy, and modified products. Provides exceptional, professional service resolving customer complaints, troubleshooting of quality issues with diverse teams, lead causal analysis activities to drive to root cause and corrective action. Ensures timely feedback from Voice of Customer, audits and KPIs for effective management review and function as the facility ISO Management Representative. Surveillance of the compliance and effectivity of the Quality Management System while using risk-based approaches to improve the QMS performance. Coordinate regulatory research to support validation and verification submissions and regulatory advice. Establishes Product Quality documentation and facilitates Quality System procedures, policies, training, implementation, and change management. Supports regulatory, registrar, and customer audits of our systems based on standards requirements. Coordinate with internal / external quality assurance auditors to ensure legal and regulatory compliance. Select and mentor quality engineers, and technicians, with development plans, growth opportunities and specific performance goals. Establishes objectives, communications, delegations, goals, tracking mechanisms (KPI), routine feedback and accountability Engage with facility leadership, continuous Improvement staff and internal teams to increase customer satisfaction by improving the capabilities of processes and product quality. Prepares product and process quality reports by collecting, analyzing, and summarizing information and trends. Ensure maintenance of all programs in the areas of Quality. Maintains all quality agreements with customers and ensures change requests are evaluated and approved. Ensures and maintains requirements, specifications, process development, risk analysis, measurement system analysis, validation, and other quality controls to assure product / component conformance. Maintain clean working environment and workplace safety standards. Generate weekly and monthly reports using quality objectives and key performance indicators (KPIs).
Other duties as required in support of the department and the company SUPERVISOR RESPONSIBILITIES Supervisory responsibilities involve overseeing and managing a team or individuals to ensure adequate performance and job satisfaction and contribute to individuals’ career goals. QUALIFICATIONS To succeed in this job, an individual must satisfactorily perform each essential job function. The requirements below represent the required knowledge, skill, and ability. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions. EDUCATION and EXPERIENCE
Bachelor’s degree in Engineering, Pharmaceutical, Chemical, Biological, Biomedical, or process related field, required 5+ years management experience with progressive experience within several Quality Areas. Medical Device and Regulatory Experience with 3+ years’ experience improving QMS. Ability to work with mathematical concepts and statistics. The ability to apply algebraic and statistical tools for analysis of product and process. Background in process validation of medical devices or flex circuit board assembly industries, preferred.
CERTIFICATES, LICENSES, REGISTRATIONS
ISO 13485 Lead Auditor certified, preferred Lean/six sigma certified and proven abilities to lead in structured problem solving, preferred
LANGUAGE REQUIREMENTS
Excellent verbal and written communication skills in English. Conversational in any other language is a plus. Clear organization and communication skills digitally as in chats, email, teams and supplier portals. Skilled verbal communicator, writer, and presenter of technical information.
MATHEMATICAL SKILLS
Ability to work with mathematical concepts and statistics. The ability to apply algebraic and statistical tools for analysis of product and process.
JOB SKILLS
Advanced in MS Office Suite and SharePoint. Software knowledge with ERP (SAP), HRIS and/or Statistical software, preferred. Judgement and decision making Quality Control Analysis Reading Comprehension Monitoring Active Listening
PHYSICAL DEMANDS As part of their job duties, the employee must sit for lengthy periods while operating a computer. They frequently use their hands to type, handle objects, and communicate verbally. Additionally, they may need to stand, walk, reach, and occasionally lift objects weighing up to twenty (20) pounds. This role requires lifting, carrying, pushing, pulling, reaching overhead, reaching at or below shoulder level, and keyboarding. According to ADA regulations, reasonable accommodation will be provided to ensure that individuals with disabilities can perform the job's essential functions. WORK ENVIRONMENT Manufacturing environment: A work environment in a manufacturing plant is the physical and social setting where goods production occurs. Depending on the type of product, process, and plant, the work environment may vary in terms of noise, temperature, safety, and demand. Common characteristics of a work environment in a manufacturing plant are the use of machinery and exposure to hazards such as chemicals, heat, dust, or noise, with a culture of teamwork, communication, and continuous improvement. ENVIRONMENTAL POLICY Amphenol CMT is fully committed to minimizing the environmental impact of its operations, activities, and products. To achieve this, we adhere to all applicable environmental regulations and laws, prevent pollution, and continuously improve our environmental performance in all our global operations. This is possible through an Environmental Management System that provides a framework for setting and reviewing our environmental objectives and targets. We aim to identify and reduce any negative environmental impact our business activities may have. PERSONAL PROTECTIVE EQUIPMENT REQUIREMENTS
ASTM F–2412–2005, ANSI Z41–1999, or ANSI Z41–1991 rated safety toe shoes in specific areas. Clear ANSI Z87.1 safety-rated glasses in specific areas. Hearing protection in specific locations. Ability to comply with job safety analysis in all areas.
EXPORT COMPLIANCE DISCLAIMER This role requires access to export-controlled information. Access may be limited to U.S. citizens, green card holders, or others authorized by U.S. law. TRAVEL Approximately 20% of travel is expected. SALARY INFORMATION: According to several states' laws, this position's salary range falls between $115,000 and $150,000 annually. However, this salary information is merely a general guideline. When extending an offer, Amphenol Critical Medical Technologies considers various factors such as the position's responsibilities, scope of work, candidate's work experience, education/training, essential skills, internal pay equity, and market considerations. Certain roles are also eligible for additional rewards, including merit increases and annual bonus. These awards are discretionary and allocated based on individual and company performance. U.S.-based employees have access to medical, dental, and vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, and wellbeing benefits, among others. U.S.-based employees also receive, per calendar year, up to 11 scheduled paid holidays, up to 80 hours of paid time off and sick paid time off.
