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Title: Engineer, Quality Assurance
Location: Portage MI (Onsite)
Duration: 12 Months with possible conversion to FT
Description:
- Work closely with Operations and Business Functions to ensure quality performance of products and processes
- Collaborate cross-functionally with internal and external teams to resolve quality issues
- Own and manage internal and supplier-driven Non-Conformances (NCs), ensuring timely investigation and closure
- Support or own Corrective and Preventive Actions (CAPAs) through root cause analysis to closure
- Disposition of non-conforming product through MRB, issuing NCs as appropriate
- Communicate with suppliers regarding NCs and escalate Supplier Corrective Action Requests (SCARs) as needed
- Participate in the development and continuous improvement of internal manufacturing processes for existing products
- Review and support Change Management activities (both supplier and internal)
- Create and/or review new or revised procedures
- Maintain and analyse KPIs to monitor product and process quality; identify trends and implement corrective actions
- Support the execution and analysis of manufacturing complaints and product field actions
- Apply statistical methods for process analysis and control
- Provide QA support during internal and external audits
- Support process/equipment validation, qualification, and Measurement System Analysis (MSA)
- Execute internal quality deliverables for engineering changes, manufacturing transfers, and supplier changes
- Assist in manufacturing/product transfers between plants/facilities, performing appropriate quality activities
- Support with product holds and executing containment Plans
- Support in risk management practices and tools, use knowledge in process risk. Support and provide input for risk management by identifying opportunities and weaknesses.
- Support and implement Lean principles through standardisation and waste elimination
- Understanding of Human Error Prevention and the application of those principles to the manufacturing environment.
- Manage supplier relationships, including but not limited to, coordinating communications, monitoring performance, managing in house and external
Qualifications & Experience:
- 0-2 years experience in a Quality or Regulatory Affairs role; prior industry experiences desirable
- Familiar with ISO 13485, GDP, and GMP concepts
- Solid understanding of engineering and quality principles, including Risk Management, CAPA, Audits, and Statistics
- Proficient in MS Word, Excel, and PowerPoint
- Strong problem-solving, analytical, and communication skills with high attention to detail
- Builds strong relationships through open communication, respect, and trust
- Team player with a customer/stakeholder-focused approach
- Diplomatic, tactful, and effective at leveraging interpersonal skills
- Embraces change with a continuous improvement mindset.
- Excellent written and spoken English
- Confident representing Quality in cross-functional settings
- Self-starter able to manage multiple tasks in a fast-paced environment
- Willing to work as part of a multi-site team; some travel required
- Knowledge of risk-based thinking and statistical concepts is a plus
Dexian stands at the forefront of Talent + Technology solutions with a presence spanning more than 70 locations worldwide and a team exceeding 10,000 professionals. As one of the largest technology and professional staffing companies and one of the largest minority-owned staffing companies in the United States, Dexian combines over 30 years of industry expertise with cutting-edge technologies to deliver comprehensive global services and support.
Dexian connects the right talent and the right technology with the right organizations to deliver trajectory-changing results that help everyone achieve their ambitions and goals. To learn more, please visit .
Dexian is an Equal Opportunity Employer that recruits and hires qualified candidates without regard to race, religion, sex, sexual orientation, gender identity, age, national origin, ancestry, citizenship, disability, or veteran status.
