What are the responsibilities and job description for the Development Quality Engineer position at SPECTRAFORCE?
Job Title : Development Quality Engineer
Location : St. Paul, MN, 55117
Duration : 12 months
Job Description :
We are seeking a Quality Assurance Engineer to join our dynamic team. The ideal candidate will have a strong background in quality management and a passion for ensuring the highest standards in product development and manufacturing.
Responsibilities :
Team Leadership and Collaboration :
Participate in or lead teams to support quality disciplines, decisions, and practices.
Collaborate with design engineering to complete customer, system, and product requirements.
Ensure timely and objective reviews of document change requests.
Design Control and Quality Plans :
Lead the on-time completion of design control deliverables.
Support the execution of Quality Plans for internal product development processes (PDP), OEM-based Clinical Product Development (CPDP), and design change projects.
Risk Management :
Lead or support risk management activities from product concept through commercialization.
Generate risk management plans and reports, including hazard analysis, FMECAs, and cybersecurity risk assessments.
Essential Outputs and Labeling :
Identify essential outputs and generate Essential Output reports.
Complete labeling verification activities and reports.
Product Verification and Validation :
Work with design engineering to complete product verification and validation.
Ensure Design History File (DHF) content completion, integrity, and regulatory and standards compliance.
Process Control and Improvement :
Identify and implement effective process control systems to support product development, qualification, and ongoing manufacturing.
Assist in the implementation of assurances, process controls, and CAPA systems.
Apply systematic problem-solving methodologies to identify, prioritize, communicate, and resolve quality issues.
Compliance and Regulatory Support :
Support company initiatives related to Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
Assist in the development and execution of streamlined business systems to identify and resolve quality issues.
Skills :
Excellent verbal and written communication
Strong interpersonal skills
Teamwork and individual contribution
Multitasking and strong organizational skills
Advanced computer skills
Education / Experience :
Bachelor's degree in an Engineering discipline or other technical field
2-5 years
