Staff Development Quality Engineer IV

TechDigital Group; Miami (FL); On-site; USD 56,826 - 80,934; Full time

Job summary

An established industry player is seeking a Staff Development Quality Engineer to lead quality functions in new product development. This role involves guiding cross-functional teams to ensure compliance with design controls and regulations, while also supporting post-launch product changes. The ideal candidate will have a strong engineering background, excellent communication skills, and a proven ability to work autonomously in a fast-paced environment. Join a dynamic team where your expertise will directly impact the quality and success of innovative products in the market.

Qualifications

• 7+ years experience in a regulated environment for Bachelor's or 5+ years for Master's.
• Experience with design controls per 21 CFR Part 820 and ISO standards.

Responsibilities

• Provide strategic direction for product development and design change teams.
• Ensure compliance with internal and international regulations.

Skills

Critical Thinking

Verbal Communication

Written Communication

Problem Solving

Multi-tasking

Education

Bachelor's degree in engineering or science

Master's degree in engineering or science

Tools

MS Office

Job description

Job #: 3245
Pay Rate: 50.00-50.00 $/hour
Job type:
Location: Miami, FL

Duration: 0-12 month(s). The Staff Development Quality Engineer supports new product development (instruments, reagents, consumables, and software) from a QA perspective. The primary role of the position is to provide guidance and direction to cross-functional core teams to meet design control requirements in support of market release of new products. The position also supports post-launch design changes for fielded products.

RESPONSIBILITIES:

1. Provide strategic direction for new product development and design change teams in terms of quality functions including design quality, manufacturing quality, process validation, supplier quality, post-market quality, and risk management.
2. Ensure proactive compliance to all applicable internal, domestic and international regulations including US 21 CFR 820 (QSR), ISO 19471:2019, and ISO 13485:2016.
3. Ensure compliant and complete product documentation, inclusive of DHFs, with particular focus on design controls, risk management, and document controls.
4. Lead extended Quality teams for new product development and design change projects.
5. Review and approve design and development documentation including Design Development plans, Design Change plans, User Needs, Design Input and Design Output documents, Design Verification Protocols and Reports, Design Validation Protocols and Reports, Software Requirement documents and associated Software Verification test procedures and reports, and System Risk Assessment documentation.
6. May review and approve engineering drawings, specifications, procedures, engineering changes, and manufacturing work instructions, etc.
7. Assure that newly developed products are successfully transferred into the supply chain including manufacturing and service environments.
8. Participate in Design Reviews and develop, approve, and review associated documentation.
9. Responsible for Design History File (DHF) completeness and maintenance.
10. Utilize problem-solving techniques and take a broad perspective to identify innovative solutions.
11. Interact frequently with other functional areas and operating entities which requires specialized depth and/or breadth of expertise.

QUALIFICATIONS:

1. Bachelor's degree in engineering or science discipline with seven years of experience in a regulated environment or master's degree in engineering or science discipline with five years of experience in a regulated environment.
2. Experience in application of design controls in accordance with 21 CFR Part 820, ISO 13485, and ISO 9001 for the development of products and design change.
3. High level of autonomy and critical thinking is required. Teamwork oriented.
4. Must be able to multi-task and prioritize in a fast-paced environment.
5. Must have strong verbal and written communication skills and be capable of producing detailed and comprehensive quality system documentation and reports.
6. Computer skills (MS Office products).
7. ASQ Certified Quality Engineer (CQE) is preferred.