Title: Production Quality Engineering Manager
Location: On-site, Lakewood, CO
Schedule: M-F 8:00-5:00/ 7:30-4:30
Pay: $120-$150k, 10% bonus (bonus, excellent healthcare benefits, unlimited PTO
Type: Direct/Permanent
Start date: Immediate

Overview:
Our client a global medical device company, is currently seeking qualified candidates for the position a global leader to be the Production Quality Engineering Manager oversee and provide leadership for the Production Quality Engineering, Validation, and In-process testing teams.  This role is integral in driving quality improvements in manufacturing, maintaining compliance to standards and regulations, and ensuring product testing is completed in timely and consistent manner.  

Responsibilities:
•   Manages and provides leadership for the team’s development, direction, and effectiveness, adhering to organizational policies and processes and supporting overall business and corporate objectives.
•    Responsible for identifying and implementing projects and initiatives to reduce defects, improve product quality, and streamline quality processes.
•    Manages the Nonconformance process to ensure the appropriate investigation of issues, timeliness of record completion, and drives a reduction in the number of nonconformances generated.
•    Collaborates with production, process engineering, R&D, and contract manufacturers as appropriate to ensure changes and nonconformances are handled appropriately.
•    Actively participates in the annual budgeting process and is responsible for managing an operation within budgetary guidelines.
•    Develops, maintains, and monitors KPIs for areas of responsibility. 
•    Analyzes quality data for trends and presents this analysis to the management team.

Requirements:

• Bachelor’s degree or equivalent of education and experience sufficient to successfully perform the essential functions of the job may be considered.
• Bachelor of Science Degree in Engineering, preferred.
• Strong leadership capabilities to ensure continuous guidance, coaching, and directing teams to success in their tasks and professional development.
• Strong project management, problem-solving, resource management skills.
• Demonstrated skills in developing, coaching, and training others in an organizational setting.
• Excellent in collaboration in working with cross-functional groups
• Strong interactive skills in cross functional participation and influence, mentoring and acceptance of guidance, technical leadership, project management, coordination with cross functional team members, team behavior, and support for subordinates, junior engineers, technicians, and management.
• Represents the organization as the main technical contact on projects. Interacts with senior level associates on significant technical matters often requiring coordination between organizations.
• Driver for acquiring resources and building consensus across teams.
• Solicits and accepts the ideas of others, as well as actively contributes to an environment conducive to open communication
• In-depth knowledge of ISO 13485 and 21CFR820 requirements
• Demonstrated ability to interact with regulatory agencies.
• Familiarity with sterilization processes, cleanroom environments, and associated product testing.
• Regularly and effectively presents complex technical information/analysis and responds to questions from technical staff members and management
• Demonstrated ability to communicate effectively both verbally and in writing.
• Knowledge and use of relevant PC software applications and skills to use them effectively.

System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, and MOUNTAIN, LTD., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.