Genesis10 is currently seeking a Quality Engineer for a contract position with a Global Medical Technology Company located in Portage, MI. This is a 12+ month contract opportunity. This role will work closely with Operations and Business Functions to ensure the quality performance of products and processes in a regulated environment. The ideal candidate will collaborate cross-functionally to resolve quality issues, manage non-conformances, and support Corrective and Preventive Actions (CAPAs).
Responsibilities: - 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, 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
- Communicate with suppliers regarding non-conformances 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 analyze 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 standardization 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
Requirements: - 0-2 years' experience in a Quality or Regulatory Affairs role; prior industry experience 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 Microsoft 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
Desired skills: - Knowledge of risk-based thinking and statistical concepts is a plus
Pay range: $42.80 - $52.80 per hour
Only candidates available and ready to work directly as Genesis10 employees will be considered for this position. If you have the described qualifications and are interested in this exciting opportunity, please apply! Ranked a Top Staffing Firm in the U.S. by Staffing Industry Analysts for six consecutive years, Genesis10 puts thousands of consultants and employees to work across the United States every year in contract, contract-for-hire, and permanent placement roles. With more than 300 active clients, Genesis10 provides access to many of the Fortune 100 firms and a variety of mid-market organizations across the full spectrum of industry verticals.
For contract roles, Genesis10 offers the benefits listed below. If this is a perm-placement opportunity, our recruiter can talk you through the unique benefits offered for that particular client. Benefits of Working with Genesis10: - Access to hundreds of clients, most who have been working with Genesis10 for 5-20+ years.
- The opportunity to have a career-home in Genesis10; many of our consultants have been working exclusively with Genesis10 for years.
- Access to an experienced, caring recruiting team (more than 7 years of experience, on average.)
- Behavioral Health Platform
- Medical, Dental, Vision
- Health Savings Account
- Voluntary Hospital Indemnity (Critical Illness & Accident)
- Voluntary Term Life Insurance
- 401K
- Sick Pay (for applicable states/municipalities)
- Commuter Benefits (Dallas, NYC, SF, and Illinois)
For multiple years running, Genesis10 has been recognized as a Top Staffing Firm in the U.S., as a Best Company for Work-Life Balance, as a Best Company for Career Growth, for Diversity, and for Leadership, amongst others. To learn more and to view all our available career opportunities, please visit us at our website.
Genesis10 is an Equal Opportunity Employer. Candidates will receive consideration without regard to their race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
