Quality Engineer

Job Title: Quality EngineerJob Description

This Quality Engineer role supports medical device product development from concept through commercialization, with a strong focus on design quality, risk management, and maintaining an effective Quality Management System. The position primarily partners with R&D and Process Engineering to ensure robust design controls, comprehensive risk management, and compliance with applicable regulatory and quality standards. Depending on experience level, the role may range from core quality engineering responsibilities to ownership of critical QMS functional areas and leadership of cross-functional quality initiatives.

Responsibilities

• Identify and implement effective quality control systems to support ongoing manufacturing and product and process development activities, ensuring internal and customer requirements are consistently met.

• Assist in improving and streamlining quality practices across the organization to effectively identify, prioritize, and resolve quality issues.

• Apply sound and systematic problem-solving methodologies to investigate, communicate, and resolve product and process quality issues.

• Lead and perform product and process risk management activities, including the use of FMEA and other risk management tools.

• Support the review, investigation, resolution, and prevention of product and process nonconformances (NCRs) in alignment with established internal requirements.

• Develop clear and effective rework procedures to support NCR activities and ensure proper disposition of nonconforming product.

• Act as a key handler for Corrective Actions and Preventive Actions (CAPA), driving appropriate risk evaluation, root cause investigation, and implementation of corrective and preventive measures.

• Support verification of effectiveness (VOE) activities for CAPAs to confirm that implemented actions resolve the underlying issues and prevent recurrence.

• Track, trend, and monitor key quality performance indicators (KPIs) and use this data to support continuous improvement of the Quality Management System.

• Prepare and report quality KPIs to the Quality Review Board (QRB) and participate in CAPA Review Board (CRB) meetings as needed.

• Review calibration out-of-tolerance assessments (OOTAs) and support the preparation of calibration remedial actions reports (RARs).

• Manage change control activities related to quality documentation, including updates to procedures, work instructions, forms, and risk management documentation.

• Serve as a quality functional approver for product and process changes as a subject matter expert in assigned areas.

• Support Document Control activities as needed, ensuring documentation is accurate, controlled, and compliant.

• Develop new quality documentation and improve existing procedures, instructions, and forms to enhance clarity and effectiveness.

• Write and execute spreadsheet validation documentation when required to ensure data integrity and compliance.

• Provide quality engineering support for process improvement initiatives and product and process development projects, ensuring high-quality solutions are implemented.

• Support complaint investigations as necessary, contributing to root cause analysis and corrective actions.

• Become part of the internal auditing team as a certified auditor and support internal audit planning and execution.

• Support backroom activities during external audits, including preparation of documentation, data, and responses.

• Provide guidance and mentorship to less experienced staff, sharing best practices in quality engineering and problem solving.

• Perform other related duties and responsibilities as assigned to support the overall effectiveness of the Quality Management System.

• For Engineer II level: take ownership of at least one critical functional area of the Quality Management System (such as CAPA, NCRs, or Deviations) and ensure its effectiveness and compliance.

• For Engineer II level: identify and implement activities to standardize and streamline quality practices across the organization, improving QMS efficiency while maintaining compliance.

• For Engineer II level: lead and coach cross-functional teams in proper root cause investigation techniques and structured problem-solving methods.

• For Engineer II level: provide guidance on the use of statistical techniques, including sampling strategies and data analysis, to support data-driven quality decisions.

• For Engineer II level: facilitate CRB, QRB, and Management Review meetings, ensuring relevant data is prepared, presented, and discussed.

• For Engineer II level: lead data trending and preparation for Management Reviews and Corporate Management Reviews to highlight performance and improvement opportunities.

• For Engineer II level: write and execute Test Method Validation (TMV) documentation related to Quality Assurance inspection methods when needed.

Essential Skills

• Hands-on experience with design controls in a medical device environment.

• Practical experience with risk management, including Design FMEA and other structured risk analysis methods.

• Experience working with Corrective and Preventive Actions (CAPA), nonconformances (NCRs), and deviations.

• Ability to apply sound, systematic problem-solving methodologies to quality issues.

• Working knowledge of ISO standards relevant to medical devices and quality systems (such as ISO 13485) and 21 CFR 820.

• Experience with risk management documentation and change control activities related to quality documentation.

• Technical understanding of quality concepts, practices, and procedures within a regulated industry.

• Medical device experience and knowledge, preferably within a manufacturing environment.

• For entry-level Quality Engineer: 12 years of experience in quality and/or quality engineering roles, preferably in medical device manufacturing.

• For Engineer II level: 25 years of experience in quality and/or quality engineering roles, preferably in medical device manufacturing.

• Ability to track, trend, and interpret quality KPIs and use data to support decision-making.

• Strong written and verbal communication skills to prepare reports, documentation, and presentations for review boards and management.

• Ability to collaborate effectively with R&D, Process Engineering, Manufacturing, and other cross-functional teams.

Additional Skills & Qualifications

• Bachelors degree in Engineering or a technical field, or equivalent technical experience.

• Experience supporting product development from concept through commercialization in a regulated medical device environment.

• Experience with internal and external audits, including participation in audit backroom activities.

• Experience developing and improving quality documentation, such as procedures, work instructions, and forms.

• Experience with spreadsheet validation and Test Method Validation (TMV) for inspection methods.

• Familiarity with statistical tools and methods for sampling and data analysis; experience with Minitab is a plus.

• Ability to facilitate or support Quality Review Board (QRB), CAPA Review Board (CRB), and Management Review meetings.

• Experience working within a formal Quality Management System and contributing to its maintenance, monitoring, and improvement.

• Capability to act as a subject matter expert and functional approver for product and process changes in assigned areas.

• Interest in or experience with becoming a certified internal auditor and participating in internal audit programs.

Work Environment

This position is fully onsite at a medical device manufacturing and development facility, operating on a first-shift schedule with flexibility to accommodate a set start time that aligns with the candidates needs. The environment is fast-paced and collaborative, with close interaction between Quality Engineering, R&D, Process Engineering, and Manufacturing teams. The local site offers high visibility for engineers, broad responsibilities across the full product lifecycle, and opportunities for career growth within a global organization focused on innovative single-use endoscopy, anesthesia, and patient monitoring solutions. The Quality Engineering team consists of four quality engineers plus leadership support, providing a strong peer network for collaboration and mentoring. Work is performed in a professional setting that follows standard medical device facility practices and quality system requirements.

Job Type & Location

This is a Contract position based out of Noblesville, IN.

Pay and Benefits

The pay range for this position is $38.46 - $52.88/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)

Workplace Type

This is a fully onsite position in Noblesville,IN.

Application Deadline

This position is anticipated to close on Oct 10, 2026.

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 [email protected] 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.