Job Title: Quality ManagerJob DescriptionThe Quality Manager oversees quality engineering activities to ensure products consistently meet established requirements and standards. This role gathers and analyzes factual data to solve complex quality-related problems, identifies and applies solutions based on technical experience and established precedents, and plans and leads quality projects with realistic timelines and clear sequencing of activities. The Quality Manager works collaboratively across all departments to build a strong team environment and drives the implementation of quality goals through audits, inspections, and testing, while closely engaging with suppliers and external experts.
Responsibilities
- Gather and analyze relevant, 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, organize, and lead quality projects by defining activities, sequencing tasks, and establishing realistic timelines.
- Evaluate process methods and equipment to ensure they meet performance and quality requirements.
- Establish quality plans for equipment and processes that support general and specific product performance needs.
- Monitor process performance against established standards and implement corrective actions when necessary.
- 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 to support quality initiatives and continuous improvement efforts.
- Facilitate team efforts on quality engineering projects and promote a collaborative, results-oriented environment.
- Communicate clearly and effectively in both oral and written form with multiple levels across the organization and with external stakeholders.
- Use optical comparators, coordinate measuring machines (CMMs), and other measurement tools to support inspection and testing activities.
- Conduct and support product testing, design assurance activities, and risk analysis using FMEA and related methodologies.
- Apply statistical methods, process control techniques, and process capability analysis to monitor and improve product and process quality.
- Maintain thorough knowledge of existing products and a basic understanding of competitive products to inform quality decisions.
- Identify inaccurate or incomplete information from supporting departments, discern potential issues, and propose corrective actions.
Essential Skills
- 57 years of experience in a Quality Engineering role, with medical device industry experience strongly preferred.
- Bachelors degree in engineering or an alternative bachelors degree combined with certification as a quality engineer (e.g., CQE).
- Strong background in quality engineering within regulated environments, ideally in medical devices.
- Proficiency in applying ISO standards and QSR requirements to processes, procedures, and supplier activities.
- Hands-on experience with FMEA, design assurance, and product testing methods.
- Expert knowledge of blueprint reading and geometric dimensioning and tolerancing (GD&T).
- Proficiency with Microsoft Office Suite for data analysis, documentation, and communication.
- Ability to use optical comparators and coordinate measuring machines (CMMs) for inspection and measurement.
- Solid understanding of statistics, process control, and process capability analysis.
- Ability to work effectively within a team environment and build strong relationships across departments and with external partners such as suppliers and regulatory agencies.
- Demonstrated ability to deliver results, meet deadlines, and maintain a strong results orientation.
- Strong oral and written communication skills, with the ability to communicate at multiple levels of the organization.
- Full working knowledge of supporting departmental needs and capabilities, including the ability to recognize inaccurate information and suggest improvements.
Additional Skills & Qualifications
- Certification as a Quality Engineer (CQE) or Reliability Engineer Certification (CRE) granted through the American Society for Quality (ASQ) is preferred.
- Experience working directly with suppliers on new product introductions and supplier quality management.
- Experience implementing and maintaining quality plans for equipment and processes.
- Familiarity with medical device regulations and standards beyond ISO and QSR.
- Thorough knowledge of existing product lines and a basic understanding of competitive products in the market.
- Strong analytical and problem-solving skills with the ability to interpret complex technical information.
- Ability to facilitate cross-functional team efforts and drive consensus on quality initiatives.
- Budget development and management experience for department and project-level activities.
Work EnvironmentThe Quality Manager works in a professional, engineering-focused environment that emphasizes cross-functional collaboration among Manufacturing, Sourcing, Development, and other supporting departments. The role involves regular interaction with suppliers and regulatory agencies, as well as hands-on work with inspection and measurement equipment such as optical comparators and coordinate measuring machines (CMMs). Daily work includes using Microsoft Office Suite for documentation, reporting, and communication, and applying ISO and QSR-based quality systems in a regulated setting, particularly aligned with medical device standards. The environment supports structured project work with defined timelines and budgets, and encourages a team-oriented, results-driven culture focused on continuous improvement and product quality. Job Type & LocationThis is a Contract position based out of Warsaw, IN. Pay and BenefitsThe pay range for this position is $45.00 - $53.00/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 14, 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.
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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.
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