Quality Generalist Manager jobs in Boulder, CO

Description

Summary:

This position will lead the efforts to ensure compliance with internal company policies and procedures for the organization, as well as international quality system standards ISO ISO9001 and AS9100.  The incumbent will provide leadership to NEO Tech facilities participating in the aerospace and defense industry and will assist in management of the relationship with the third party notified bodies.

Essential Duties and Responsibilities:

• Champion continuous quality improvement efforts and defect reduction initiatives to establish an effective Quality Management Systems (QMSs); initiate and implement quality improvement activities, meeting various quality ISO and other standards to raise the performance of the company’s KPIs and quality objectives across product lines.
• Understand and drive regulatory standards pertaining to aerospace and defense (ISO9001 and AS9100) as they are related to the organization’s Quality Management System, while serving as the company’s site quality management representative (QMR).
• Assume the role of the ISO regulatory and quality expert.
• Risk Management/FMEA.
• Process Validation.
• Adhere to all safety and health rules and regulations associated with this position and as directed organization and flow down the requirements through the quality management systems.
• Ensure the promotion and awareness of regulatory medical requirements as the quality management representative, while applying cGMP philosophy.
• Drive continuous improvement through trend reporting analysis and metrics management, ensuring processes and procedures are effective and efficient.
• Lead and train department on key quality analysis tools including SPC, DoE, QFD, Root Cause Analysis, 6 Sigma and Lean methodologies.
• Analyze quality issues throughout the value chain and lead issues resolution including CAPA management, to successful conclusion. Perform data mining analytics for continual improvement of future products, business processes, and customer satisfaction.
• Training - train and/or provide necessary training related to accept/reject criteria and workmanship standards.
• Training – review training matrix on a periodic basis and communicate training requirements to each department supervisor.
• Control and maintenance of the Calibration System and preventive maintenance program.
• Work with suppliers to ensure their quality systems are acceptable.
• Support and follow all ISO standards related to OnCore’s various Quality Management Systems.  These systems may include, but are not limited to, quality, the environment, health, safety and security.
• QMS Management Representative.
• Ensure that the quality management system is implemented and maintained;
• Promote awareness of regulatory and customer requirements throughout the organization;
• Report to the top management on the efficiency and performance of the quality systems.
• Coordinate communication with external parties on matters relating to the quality system and ISO certifications.
• Perform other duties, as assigned.

Qualifications

Job Knowledge, Skills & Abilities:

• Regulatory ISO 9001 and AS9100 certifications.
• Demonstrated commitment to customer service.
• Ability to anticipate, meet and exceed expectations by solving problems quickly and effectively, making customer issues a priority.
• Lean and 6 Sigma methodologies.

Experience/Education:

• Bachelor degree in Engineering or related field.
• Minimum 8 years of experience developing, implementing and maintaining regulatory systems in the medical device industry.
• Experience with regulatory agency inspections, customer compliance audits and international requirements.

Salary Range:  $78,195 to $117,000 annually

Benefits Offered: Comprehensive benefit package including medical, dental and vision coverage; company-paid basic life/AD&D insurance, short-term and long-term disability insurance; voluntary supplemental insurances, flexible spending accounts and employee assistance program (EAP). Sick Leave, Vacation Time, and company-paid Holidays are also provided as paid time off. NEOTech also provides a 401(k) Retirement Savings Plan option with a company match.

NEOTech is an Equal Opportunity/Affirmative Action employer.  All qualified applicants will receive consideration for employment without regard to race, color, religion, sex including sexual orientation and gender identity, national origin, disability, protected Veteran status, or any other characteristic protected by applicable federal, state, or local law.

NEOTech has a long-standing commitment to maintaining a safe, quality-oriented and productive work environment.  We also want all employees to perform their duties safely and efficiently, in a manner that protects their interests and those of their co-workers. We recognize that alcohol and drug abuse pose a threat to the health and safety of NEOTech employees and to the security of the Company’s equipment and facilities. For these reasons, NEOTech is committed to the elimination of drug and alcohol use and abuse in the workplace.  Candidates being considered for hire must pass a pre-employment background check and drug test which include screening for illegal drugs and marijuana.