Responsible for the planning and coordinating of quality engineering activities (Design Controls, Test Method Validation, Process Validation, Annual product reviews, continued process verification), quality records support in electronic systems such as Trackwise, Docusign, etc. to ensure all of these activities are performed in a timely manner to meet company procedures.

• Provides support in the coordination of all Quality Engineering Activities
  • Update documents based on inputs from stakeholders and obtain paper / electronic approvals
  • Manage Change requests in Trackwise and coordinate with stakeholders for timely completion
  • Arrange and maintain departmental folders for easy access
  • Obtains data from various departments and assembles for analysis
• Tracks departmental activities and provides reminders for upcoming tasks
• Performs all activities with quality focus, engineering principles, and attention to detail
• Participates and supports in continuous improvement projects
• Communicate/escalate roadblocks and find innovative ways to address them
• Communicates progress to management

Participates in manufacturing, R&D and partner meetings to understand priorities and schedule work to support customer needs

Competencies:

• Strong writing and oral communication, and organizational skills.
• Attention to detail and accuracy
• Excellent Computer literacy in Microsoft Word, Excel, PowerPoint, Trackwise, and LIMS.
• Strong project management skills
• Ability to work under pressure with multiple tasks and deadlines.
• Ability to work independently as well as with key internal and external members. 
• Ability to multi-task and integrate project segments.
• Time management skills and the ability to prioritize work
• Data management and Problem-solving
• Team work, Adaptability, and Confidentiality

Education & Experience:

Bachelor’s degree with at least one-year experience. Engineering / science degree is preferred. Proficient in use of email and internet; good numeracy skills; accurate keyboard skills; Excellent knowledge of office management systems (Microsoft Word, Excel, PowerPoint, Visio, and Outlook) and procedures; knowledge of basic accounting procedures. Must be able to work independently or collaboratively in a team environment. Experience with Trackwise, DocuSign, VeevaVault is preferred. Basic knowledge of engineering and statistics is preferred.

Work Environment:

Air-conditioned office environment.  Majority of time spent sitting at desk, operating computer and talking on telephone. May require to participate in activities on manufacturing and / or laboratory areas.

Physical Demands:

Ability to lift at least 50 pounds, visual and manual dexterity required to perform clerical duties, including operating office equipment and checking documents for accuracy. 

Occasional extra hours required to meet project deadlines.  Attention is frequently shifted between multiple priorities.