QMS Document Control Supervisor

The QMS Document Control Supervisor collaborates directly with the Quality and the Manufacturing departments to create, maintain, and control effective work instructions and documentation in a timely manner. This is an on-site position located in Beaverton Oregon.

• Technical, Engineering, or Business certification or degree
• Experience in ISO 9001, ISO 13485, and/or AS9100 quality standards
• Basic Bill of Material (BOM), Component Identification, and PCBA Assembly
• Documentation experience in electronics manufacturing
• Experience with Good Documentation Practices (GDocP)

The physical demands and work environment characteristics described above are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

• →Lead the document control team by:

o   Communicating vision, policy, procedure, and plans

o   Coaching and mentoring to obtain and maintain needed skill and performance

o   Bringing about constructive and necessary changes

• →Perform and support the day-to-day documentation management activities by:

o   Collaborating cross-functionally with Subject Matter Experts (SMEs) from Manufacturing, Quality, Supply Chain, Program Management, and Facilities to ensure document accuracy.

o   Ensuring QMS documentation adheres to regulatory requirements and internal policies.

o   Creating, formatting, editing, routing, finalizing, filing, and maintaining all controlled documents within the Quality Management System.

o   Creating, updating, and releasing manufacturing work instructions, and printing production labels to support the manufacturing schedule.

o   Ensuring periodic document reviews are conducted per allotted time frames.

o   Providing training and support in answering questions about Quality Management System processes relating to Change Management and Document Control.

• →As a working supervisor, perform document preparation work alongside the team — including production documentation and/or labels — and back up document control personnel as workload requires
• →Support configuration of Agile system
• →Support IT by performing Software Validations
• →Identify and lead continuous improvement of documentation processes, templates, and tools to reduce document preparation cycle time and errors
• →Performs other duties as assigned.

• →Plan and monitor work to be accomplished by team members
• →Allocate resources to obtain effective and timely results
• →Delegate authority to team members when needed
• →Be a technical resource to production for process operation, improvement, and problem solving
• →Define and update job descriptions, requirements, and expectations for various teams
• →Interview and select personnel
• →Manage personnel schedules, time off, and payroll approvals
• →Performance management including performance appraisals and disciplinary action

Advanced level of proficiency in computer systems, including Microsoft Office tools, data entry, graphic applications, CAD and photo editing software

English (reading, writing, and verbal)

General math skills and ability

• Demonstrated self-motivation, problem solving abilities, team spirit, and a “hands on” mentality.
• Demonstrated proactive follow-up, relationship building, and negotiating skills.
• Strong attention to detail, accuracy, and thoroughness regarding complex drawings, text, and data in numerous formats.
• Flexibility and service-oriented attitude.
• Ability to cooperate and collaborate effectively with multiple, matrixed teams.
• Strong communication skills, both written and oral.
• Ability to lead and develop competency of others.
• Ability to initiate and lead improvements.
• Communicate in person, over the phone, email, internet, or in writing in a positive and professional manner at all times.
• Ability to manage multiple time-sensitive priorities and organize workload effectively.
• Ability to work with minimal supervision and make productive use of time.

• High School Diploma, GED or Equivalent
• Doc Control/Configuration Management Software and standard processes including file structures, release, and change control processes.
• Experience with documentation control practices in a manufacturing environment
• Demonstrated experience as a competent role model