Irvine, California - Direct Hire - Job ID #495
Ensures that the company’s Quality Management System consistently meet or exceed established quality standards and requirements. Manages the Quality System effectiveness and ensure it
continues to meet compliance and standard requirements. Applies quality concepts to systems,
processes, operations, and products. Maintains company quality activities including coordination of audits, NCs, CAPA, NCMs and Good Manufacturing Practices. Works towards effectively achieving improved product performance, lean operational performance, and cost objectives. Assists the director in developing and maintaining the quality assurance organization. Ensure that processes and work practices are documented and are efficient, effective, and compliant to local, state, federal and international regulations which pertain to worker health and safety, medical device safety and effectiveness, and environmental protection. Manages and monitors quality metric and key performance indicators.
Manage Quality deliverables for new product development and sustaining activities including validations (device, equipment, process operational), Supplier Quality requirements, PFMEAs, Inspection Control Plans, Process Control plans, CTQs, change controls, PPAP and customer requirements.
Requires a bachelor's degree and 3 years management experience in the field. Relies on extensive experience and judgment to plan and accomplish goals. Performs a variety of tasks. Leads and directs the work of others. A wide degree of creativity and latitude is expected.
• Daily management of resources of Quality Assurance department.
• Ensure that company quality standards for manufactured and repaired products are adhered to consistently.
• Oversee the process of discrepant/nonconforming materials reports and where appropriate, initiate corrective actions.
• Monitor open corrective action reports and supplier non-conformances. Create and implement corrective actions.
• Ability to perform R/C analysis and provide plans/strategies to resolve problems.
• Prepare Quality Assurance reports (metrics and KPIs), Management Review metrics and present status in review meetings and at designated intervals.
• Perform annual internal and supplier audits and inspections.
• Report audit and inspection findings to management team/CEO.
• Ensure quality system training is performed for all new employees and at designated intervals and where required.
• Create, maintain and improve procedures/SOPs to ensure continued compliance and effective
• Ensures all drawings are reviewed for accuracy and establishment of CTQs from a risk and product performance-based approach.
• Ensure Supplier Quality, nonconforming material processing and CAPA programs.
• Oversee operational validation, PM and calibration programs.
• Oversee process flow charts, PFMEA, capability studies and other PPAP type support activities.
• Ensure quality systems meet customer contractual requirements.
• Effect Good Manufacturing and Good Documentation practices.
• Primary internal contacts are with entire organization through daily contact and problem- solving oriented team meetings. Key external contacts include customers, industry, contractors, and vendors.
• Carries out management responsibilities in accordance with the organization’s policies and applicable laws.
• Interview, hire/fire/evaluations/discipline and training/development of employees.
• Produce and maintain annual training plan.
• Oversee document control activities.
• Ensure Quality projects are assigned appropriate resources, are completed on schedule, and within budget.
SKILLS AND QUALIFICATIONS:
Knowledge and complete understanding of Quality System Regulations, ISO 13485 Quality System Standard, 21 CFR part 820, EU Med Device regulations and other applicable regulatory laws and requirements, Managerial, communication, computer, and shop measuring equipment
skills required. Knowledge of Microsoft Word and Excel spreadsheet are essential. Ability to work with mathematical concepts such as probability and statistical inference. Ability to apply
concepts such as fractions, percentages, ratios, and proportions to practical situations. Ability to analyze trends and draw logical conclusions. Proficient at lean methodologies and quality tools such as RC analysis, tolerance analysis, six sigma, SPC, Risk Management (PFMEA, DFMEA,
Risk Analysis, etc). Must have audit experience.
Must be able to manage direct reports, provide employee development and maintain company culture objectives.
Critical thinking, facilitation, and negotiation skills and abilities essential. Must be able to verbally communicate clearly and concisely and in writing.
Must be able to professionally collaborate with internal cross functional partners, external suppliers and customers.
Must be able to manage projects and provide tangible deliverables.
Expected to self-manage and to report/escalate issues where appropriate and where business and product risks become known. Works toward predetermined, long-range goals.
EDUCATION AND EXPERIENCE:
Four-year college degree, preferably in technical or life science. Five or more years of experience in Quality Management with experience in manufacturing organization. 3 years
previous management background with multiple direct reports is necessary. Must have
experience working with Quality Management systems and Quality System Regulations. Must have background working with the FDA. Experience in government regulations, quality/regulatory management systems, operational auditing, workflow analysis, adult learning/training, technical writing, and manufacturing operations. Education in quality management problem-solving tools.
INTERPERSONAL AND COMMUNICATIONS SKILLS:
Position requires regular contact both inside and outside the company at all organizational levels in order to carry out company business, policies, procedures, and regulations. Involves
considerable tact, discretion, and persuasion in order to obtain willing action and consent. Regular contacts include, but are not limited to, the company CEO, the Quality Control
Supervisor, Returns Manager, Operational Management, and the Finished Product Testing Supervisor and Engineering Management. Contact with employees, customers, and vendors is frequent. Position requires regular contact both inside and outside the company at all
organizational levels. Involves good interpersonal and communication skills to exercise considerable tact, discretion, and persuasion in order to obtain willing action and consent.