Development Quality Engineer II

Experis; Saint Paul (MN); On-site; USD 32,000 - 52,000; Full time

Job summary

Experis is seeking a Development Quality Engineer II in Saint Paul, MN for a 12-month, onsite role. Compensation ranges from $35 to $38 per hour on W2.

The role focuses on leading quality disciplines, design control deliverables, and risk management across PDP/CPDP projects, with heavy emphasis on regulatory compliance and device manufacturing support. The candidate will contribute to plan development, verification and validation activities, issue essential output reports, and maintain DHF

Qualifications

• Bachelor degree in engineering or technical field.
• 2-5 years of R&D, process/manufacturing engineering, or quality.
• Experience in medical devices and related regulations/standards.
• Process validation planning and execution experience.
• Inspection or test method validation experience.

Responsibilities

• Participate in or lead teams in supporting quality disciplines, decisions, and practices.
• Lead on-time completions of design control deliverables.
• Support on-time execution of Quality Plans for PDP, CPDP and design change projects.
• Gen­eration of process validation test plans/reports.
• Gen­eration of PDP design verification test plans/reports for product requirements.
• Lead or support risk management activities from concept through commercialization.
• Identify essential outputs and generate Essential Output reports.
• Complete labeling verification activities and reports.
• Collaborate with process engineering on manufacturing and validation deliverables.
• Ensure DHF content integrity and regulatory compliance.
• Support device manufacturing activities from concept to commercialization.

Skills

Quality engineering

Design control

Risk management

Validation & Verification (V&V)

Regulatory compliance

Education

Bachelor's degree in engineering or technical field

2-5 years of R&D/Process/Manufacturing Engineering or Quality

Tools

FMEA

CAPA

GMP

Job description

Title: Development Quality Engineer II

Location: St. Paul, MN (100% Onsite)

Duration: 12 months

Pay Range: $35/hr to $38/hr (On W2)

We are looking for a“Development Quality Engineer II“to join one of our Fortune 500 clients.

Job Responsibilities

• Participate in or lead teams in supporting quality disciplines, decisions, and practices


• Lead on-time completions of design control deliverables


• Support on-time execution of Quality Plans for internal product development process (PDP), OEM-based Clinical Product Development (CPDP) and design change projects


• Accountable for generation of process validation test plans/reports


• Accountable for generation of PDP design verification test plans/reports for product/system requirements


• Lead or support Risk Management activities from product concept through commercialization, including generation of risk management plans/reports, completion and maintenance of hazard analysis, FMEAs, and Cybersecurity risk assessments


• Lead identification of essential outputs and generate Essential Output reports


• Accountable for completion of labeling verification activities and labeling verification reports


• Work with process engineering in the completion of manufacturing process deliverables such as manufacturing procedures and inspection procedures


• Work with process engineering in the completion of process validation deliverables such as inspection and test method development and equipment qualification


• Work with design engineering in the completion of customer/system/product requirements


• Work with design engineering in the completion of product verification and validation


• Ensure DHF content completion, integrity, and regulatory / standards compliance


• Support device manufacturing activities from product concept through commercialization


• Collaborative communication resolving gaps


• Complete document change request reviews in a timely and objective manner


• Identify and implement effective process control systems to support the development, qualification and on-going manufacturing of products to meet or exceed internal and external requirements


• Assist in the implementation of assurances, process controls and CAPA systems designed to meet or exceed internal and external requirements


• Assist in tech development and execution of streamlined business systems which effectively identify and resolve quality issues


• Apply sound, systematic problem solving methodologies in identifying, prioritizing, communicating and resolving quality issues


• Support all company initiatives as identified by management and in support of quality management systems (QMS), Environmental Management Systems (EMS) and other regulatory requirements


• Ability to maintain regular and predictable attendance on-site


• Additional duties may be identified by functional management based on the current project/business objectives

Education

• Bachelor level degree in an Engineering Discipline or other technical field experience


• 2-5 years of experience in R&D, Process/Manufacturing Engineering, and/or Quality with at least 1 year direct quality manufacturing support experience


• Experience in medical devices and associated regulations/standards


• Experience in process validation planning and execution


• Experience in inspection method validation or test method validation

Preferred Qualifications

• 2+ years in direct quality manufacturing support experience


• Experience in preparing risk assessments, FMEA, and other risk documents


• Experience with reflow and injection molding processes

We are looking for the candidate who are eligible to work with any employers without sponsorship