Job Description

Job Description

Job Description

Job Title: Sr. Quality Engineer

Duration: 12+ Months (Possible extension)

Location:  Spencer, IN 47460

Onsite Role

Responsibilities:

• Working with smaller team size (less than 8) on remediation efforts of FDA findings.
• Medical Device experience
• Analytical thinker
• Strong experienced in technical writing
• Develops, establishes and maintains quality engineering methodologies, systems, and practices which meet client, customer, and regulatory requirements.
• Provides focused quality engineering support within new product development, operational, or system/services support.
• Provides leadership role on championing departmental or cross-functional engineering initiatives.
• Provides project direction, coaching, and mentoring for engineering and technical team personnel.
• Proactively investigates, identifies, and implements best-in-class Quality Engineering practices.
• Mentor for technical guidance for identifying and resolving quality issues.
• Identifies and implements effective process control systems to support the development, qualification, and on-going manufacturing of products to meet or exceed internal and external requirements.
• Leads in the implementation of assurances, process controls, and CAPA systems designed to meet or exceed internal and external requirements.
• Acts as an effective leader or team member in supporting quality disciplines, decisions, and practices.
• Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
• Assures the development and execution of streamlined business systems which effectively identify and resolve quality issues.

Education/Experience:

• 5 - 7 Years with BS, 3 - 6 Years with MS
• Medical Device experience
• Must be an analytical thinker
• Technical writing experience

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