Development Quality Engineer I

Job Specifications:
Title : Development Quality Engineer I I
Location: Plymouth, MN, 55442
Duration: 12 Months'

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 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.
• FMECA's and Cybersecurity risk assessments.
• Lead identification of essential outputs.
• Generate essential output reports.
• Accountable for completion of labeling verification activities and labeling verification reports.
• Work with design engineering in the completion of customer/system/product requirements.
• Work with design engineering in the completion of product verification and validation.
• Endure DHF content completion, integrity and regulatory & standards compliance.
• 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.
• Additional duties may be identified by functional management based on the current project/business objectives.

Qualification and Responsibilities:

• Primary focusing on gap assessment and remediation.
• Having EUMDR assessment experience
• Having China PTR with product specification and validation exposure.
• Medical device experience preferred
• Pharma would be okay
• Familiar with design control
• 2-5 years of experience, flexible
• Having R&D and product development experience would be an added advantage.
• Author protocols and reports- Design verification, protocol writing.