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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