Development Quality Engineer II
Development Quality Engineer II
Posted on :
08-06-2025
Employer Active
1 Vacancy
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Job Description
- Experience: 2 5 years required
- Education: Bachelors degree in Engineering or technical field
- Skills:
- Strong verbal and written communication
- Effective interpersonal and teamwork abilities
- Ability to work independently as an individual contributor
- Excellent multitasking and organizational skills
- Advanced computer proficiency
Key Responsibilities:
- Participate in or lead teams to support quality disciplines decisions and practices
- Lead on-time completion of design control deliverables
- Support timely execution of Quality Plans for internal PDP OEM-based CPDP and design change projects
- Generate design verification test plans and reports for product/system requirements
- Lead or support Risk Management from concept through commercialization including plans reports hazard analysis FMECA and cybersecurity risk assessments
- Identify essential outputs and generate related reports
- Complete labeling verification activities and reports
- Collaborate with design engineering for customer/system/product requirements and product verification/validation
- Ensure Design History File (DHF) content completion integrity and compliance with regulations and standards
- Communicate and resolve gaps collaboratively
- Review document change requests promptly and objectively
- Identify and implement effective process controls to support product development qualification and manufacturing
- Assist in implementing assurance process controls and CAPA systems to meet/exceed requirements
- Assist in the development and execution of streamlined business systems to resolve quality issues
- Apply systematic problem-solving methodologies to identify prioritize communicate and resolve quality issues
- Support company initiatives related to QMS EMS and regulatory requirements
- Perform additional duties as assigned by management based on business objectives
Work Schedule: 8:00 AM 5:00 PM
- Education: Bachelors degree in Engineering or technical field
- Skills:
- Strong verbal and written communication
- Effective interpersonal and teamwork abilities
- Ability to work independently as an individual contributor
- Excellent multitasking and organizational skills
- Advanced computer proficiency
Key Responsibilities:
- Participate in or lead teams to support quality disciplines decisions and practices
- Lead on-time completion of design control deliverables
- Support timely execution of Quality Plans for internal PDP OEM-based CPDP and design change projects
- Generate design verification test plans and reports for product/system requirements
- Lead or support Risk Management from concept through commercialization including plans reports hazard analysis FMECA and cybersecurity risk assessments
- Identify essential outputs and generate related reports
- Complete labeling verification activities and reports
- Collaborate with design engineering for customer/system/product requirements and product verification/validation
- Ensure Design History File (DHF) content completion integrity and compliance with regulations and standards
- Communicate and resolve gaps collaboratively
- Review document change requests promptly and objectively
- Identify and implement effective process controls to support product development qualification and manufacturing
- Assist in implementing assurance process controls and CAPA systems to meet/exceed requirements
- Assist in the development and execution of streamlined business systems to resolve quality issues
- Apply systematic problem-solving methodologies to identify prioritize communicate and resolve quality issues
- Support company initiatives related to QMS EMS and regulatory requirements
- Perform additional duties as assigned by management based on business objectives
Work Schedule: 8:00 AM 5:00 PM
Employment Type
Full Time
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