Quality Sr Engineer II

Job Title: Quality Senior Engineer IIJob DescriptionThe Quality Senior Engineer II is responsible for solving complex quality-related problems by gathering and analyzing relevant data, applying technical expertise, and leveraging established precedents. This role leads quality engineering projects, establishes and maintains quality plans, and ensures that products and processes conform to all applicable standards and regulatory requirements. The position works closely with cross-functional teams, suppliers, and external experts to support new product introductions, continuous improvement, and the achievement of organizational quality goals.

Responsibilities

• Gather and analyze factual information and data to identify, investigate, and resolve quality-related issues.
• Apply technical experience and established precedents to develop and implement effective solutions to quality problems.
• Plan and lead quality engineering projects by defining activities, organizing them into time-dependent sequences, and setting realistic timelines.
• Develop a collaborative team atmosphere and work productively with all departments to achieve quality objectives.
• Assure that products conform to established requirements and standards through appropriate audit, inspection, and test activities.
• Evaluate process methods and equipment to ensure they meet performance and quality requirements.
• Establish quality plans for equipment and processes that address general and specific product performance needs.
• Monitor process performance against defined standards and take action to maintain or improve capability and compliance.
• Apply ISO and Quality System Regulation (QSR) requirements to internal processes and procedures as well as to those of external suppliers.
• Collaborate with suppliers on new product introductions to ensure quality and performance requirements are fully met.
• Assist Manufacturing, Sourcing, and Development teams in interpreting and applying applicable regulations and quality standards.
• Develop and maintain department and project budgets, ensuring that quality initiatives are appropriately planned and resourced.
• Facilitate team efforts on quality engineering projects, providing guidance and technical support.
• Communicate project status, quality issues, and recommendations clearly and effectively in both oral and written form to multiple organizational levels.
• Identify inaccurate or incomplete information related to quality or processes, and propose corrective actions and improvements.

Essential Skills

• 57 years of experience in a Quality Engineering role, with medical device industry experience strongly preferred, or an equivalent combination of education and experience.
• Bachelor of Science degree in engineering, or an alternative bachelors degree combined with certification as a quality engineer (e.g., CQE).
• Strong quality engineering expertise, including experience with audits, inspections, testing, and quality planning.
• Expert-level blueprint reading skills and proficiency in geometric dimensioning and tolerancing (GD&T).
• Ability to work effectively in a team environment and build strong relationships across departments and with external suppliers and regulatory agencies.
• Proven ability to lead projects, manage timelines, and consistently meet deadlines with a strong results orientation.
• Excellent oral and written communication skills, with the ability to communicate effectively at multiple levels of the organization.
• Proficiency with the Microsoft Office Suite for data analysis, documentation, and communication.
• Understanding and practical application of QSR and ISO regulations to processes and procedures.
• Hands-on experience with design assurance activities, Failure Modes and Effects Analysis (FMEA), and product testing methods.
• Ability to operate and interpret measurements from optical comparators and coordinate measuring machines (CMMs).
• Solid knowledge of statistics, statistical process control (SPC), and process capability analysis.
• Full working knowledge of supporting department needs and capabilities, with the ability to recognize inaccurate information and suggest corrective approaches.
• Thorough knowledge of existing products in the portfolio and a basic understanding of competitive products.
• Certification as a Quality Engineer (CQE) or Reliability Engineer (CRE) through the American Society for Quality (ASQ) is preferred.

Additional Skills & Qualifications

• Experience in the medical device industry, including familiarity with applicable regulatory standards and product performance requirements, is strongly preferred.
• Ability to facilitate cross-functional team efforts on quality engineering projects and drive consensus on quality solutions.
• Strong analytical and problem-solving skills, with the ability to interpret complex data and translate findings into actionable improvements.
• Demonstrated capability to develop and manage department and project budgets related to quality initiatives.
• Knowledge of design assurance practices and risk management methodologies in a regulated environment.
• Professional certifications such as CQE or CRE from ASQ are desirable and considered a plus.
• Adaptability in working with suppliers and external experts to support new product introductions and continuous improvement.
• Results-focused mindset with a commitment to maintaining high quality standards and regulatory compliance.

Work EnvironmentThis position is based fully onsite, working within a regulated manufacturing and engineering environment focused on medical devices. The role involves close collaboration with cross-functional teams such as Manufacturing, Sourcing, and Development, as well as interaction with external suppliers and regulatory agencies. Work is performed in office and production areas using standard computer tools, including the Microsoft Office Suite, and precision measurement equipment such as optical comparators and coordinate measuring machines (CMMs). The environment emphasizes adherence to ISO and QSR requirements, robust documentation practices, and continuous improvement of processes and product quality. Professional attire appropriate for an engineering and manufacturing setting is expected, with additional safety or cleanroom requirements as applicable to specific areas. Job Type & LocationThis is a Contract position based out of Warsaw, IN. Pay and BenefitsThe pay range for this position is $45.00 - $58.00/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) Job Type & LocationThis is a Contract position based out of Warsaw, IN. Application DeadlineThis position is anticipated to close on Nov 21, 2026. Workplace TypeThis is a fully onsite position in Warsaw,IN.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 actalentaccommodation@actalentservices.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.