Quality Engineer

Job Description

Job Description

Job Title: Engineer, Quality Assurance

Job Description

The Engineer, Quality Assurance will play a proactive role in supporting quality assurance, quality control, and preventive activities to ensure compliance with regulations and standards. This role involves collaborating with cross-functional teams, assisting in resolving quality issues, and contributing to continuous improvement initiatives within manufacturing and quality processes.

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 (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 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.
• Execute and analyze Quality Acceptance Tests (QATs).
• Support with product holds and executing containment plans.
• Support in risk management practices and tools, identifying opportunities and weaknesses.
• Support and implement Lean principles through standardization and waste elimination.
• Understand Human Error Prevention and apply those principles to the manufacturing environment.
• Manage supplier relationships, coordinating communications, monitoring performance, managing nonconformities, and ensuring timely delivery of quality materials and services.

Essential Skills

• Proficient in quality engineering, root cause analysis, and Quality/manufacturing engineering.
• Familiar with ISO, medical device standards, and regulatory affairs.
• 02 years experience in a Quality or Regulatory Affairs role.
• 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.
• 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.

Additional Skills & Qualifications

• Familiar with GDP and GMP concepts.
• Team player with a customer/stakeholder -focused approach.
• Diplomatic, tactful, and effective at leveraging interpersonal skills.
• Embraces change with a continuous improvement mindset.
• Knowledge of risk-based thinking and statistical concepts is a plus.

This is a Contract position based out of Portage, MI.

The pay range for this position is $52.00 - $52.00/hr.

Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: Medical, dental & vision Critical Illness, Accident, and Hospital 401(k) Retirement Plan Pre-tax and Roth post-tax contributions available Life Insurance (Voluntary Life & AD&D for the employee and dependents) Short and long-term disability Health Spending Account (HSA) Transportation benefits Employee Assistance Program Time Off/Leave (PTO, Vacation or Sick Leave)

This is a Contract position based out of Portage, MI.

This position is anticipated to close on Nov 13, 2026.

This is a fully onsite position in Portage,MI.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email View email address on ziprecruiter.com for other accommodation options.

San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.

Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.