Quality Engineer II - Defined Term
About The Position
The Quality Engineer II will utilize quality engineering methodologies, systems and practices within a manufacturing environment. This is a one-year defined-term position dedicated to supporting Project Astria, a sustaining manufacturing initiative focused on Cardiac Rhythm Management (CRM) and Neuromodulation (NM) final packaging operations at the Quincy Distribution Center (DC). As the dedicated Quality resource supporting Project Astria, this engineer will serve as a key Quality representative responsible for implementing manufacturing process controls, communicating quality assurance requirements and supporting divisional and corporate quality initiatives, goals and objectives. This role offers the opportunity to be a key contributor within a growing production support area while ensuring the continued quality, compliance and performance of manufacturing operations.
Requirements
- Bachelor's degree in engineering, technology, life science or a related discipline.
- Minimum of 2 years' experience in the medical device industry or a similar regulated industry in a role directly supporting manufacturing or production.
- Experience with Lean manufacturing, Six Sigma methodologies, process improvement and root cause analysis.
- Strong critical thinking and problem-solving skills.
- Excellent interpersonal, communication and relationship-building skills.
- Ability to work effectively in a cross-functional team environment.
- Ability to travel up to 10%.
Nice To Haves
- Experience supporting supply chain or distribution operations.
- Exposure to packaging and final packaging manufacturing requirements.
- Exposure to localization requirements.
- Proven ability to influence without direct authority.
- Strong attention to detail.
Responsibilities
- Identify and implement effective process control systems to support the development, qualification and ongoing manufacturing of products that meet or exceed internal and external requirements.
- Serve as an effective team contributor by supporting quality disciplines, decisions and best practices.
- Apply systematic problem-solving methodologies to identify, prioritize, communicate and resolve quality issues.
- Support the development and execution of consistent, streamlined business systems that effectively identify and resolve quality issues.
- Collaborate cross-functionally with local and divisional team members on assigned projects to ensure compliance with quality system requirements.
- Evaluate, review and approve project plans, risk management files and process verification activities.
- Provide quality engineering support for Project Astria, ensuring compliant and efficient sustaining manufacturing operations for Cardiac Rhythm Management and Neuromodulation final packaging at the Quincy Distribution Center.
- Demonstrate a primary commitment to patient safety and product quality by maintaining compliance with the Quality Policy and all documented quality processes and procedures.
Benefits
- Access to the latest tools, information and training
- Support in progressing skills and career
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
