Reliability Engineer

Advantage Technical is hiring a Reliability Engineer in the Bloomington, IN area. Join a collaborative team focused on improving patient outcomes through data-driven investigations and continuous product improvement.

Pay: $44.00/hour

Qualifications:

• Bachelor's Degree (BS) in Engineering, Life Sciences, or related field with 2-4 years of relevant experience
• OR
• Master's Degree (MS) with 1-2 years of experience
• Experience working in FDA-regulated environments, preferably within medical devices or life sciences
• Strong technical writing and documentation skills (SOPs, validations, quality reports)
• Organized, detail-oriented, and an analytical thinker with excellent problem-solving abilities
• Familiarity with ISO 13485, 21 CFR Part 820, CAPA systems, and QMS tools

Preferred Skills:

• Knowledge of remediation planning, regulatory inspections, and compliance gap closure
• Experience working in small teams or cross-functional environments
• Exposure to Design Assurance, Supplier Quality, or Metrology functions is a plus
• Hands-on experience with data analysis tools, risk assessment, and validation documentation

This role develops, implements, and maintains quality engineering systems and practices that meet FDA, ISO 13485, and company standards. You'll act as a key quality representative, ensuring visibility, alignment, and communication of quality initiatives across engineering, manufacturing, and compliance teams. You'll support quality across the product lifecycle in areas such as design assurance, operations quality, supplier quality, metrology, and system services.

Key Responsibilities:

• Lead the remediation of FDA findings, working closely with internal stakeholders to implement sustainable, compliant solutions.
• Develop and enhance process control systems to support product development, validation, and ongoing production.
• Support and lead the execution of CAPA systems, risk management strategies, and quality improvement initiatives.
• Apply structured problem-solving techniques (e.g., Root Cause Analysis, 5 Whys, Fishbone Diagrams, DMAIC) to resolve quality issues effectively.
• Champion a culture of quality by ensuring business processes align with regulatory standards and company objectives.
• Serve as a quality leader or team member, providing guidance on best practices, audit readiness, and system improvements.
• Ensure quality is built into every stage of design, development, and production.

Employee Benefits

Enjoy a comprehensive benefits package that includes medical, dental, vision, and pet insurance; a 401(k) retirement plan; health savings accounts (HSA); commuter and parking benefits; life and AD&D coverage; an employee assistance program (EAP); and access to exclusive discounts and perks.

Ready to apply your skills to support innovation in patient care? Click "Apply Now" to be considered for this opportunity!

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With company roots going back over 30 years, Advantage Technical is an engineering and information technology services company and a national leader in the provision of technical resources today. These services include Staff Augmentation, Direct Placement, Project Resourcing and Outsourcing - delivered from 40 key market locations, by over 3500 specialized contractors, to over 500 clients across North America. Advantage Technical is a Best of Staffing Diamond Award winner for both Clients and Talent. For more information about the industries and services offered by Advantage Technical, please visit AdvantageTechnical.com.

Advantage Technical is committed to providing equal employment opportunity for all persons regardless of race, color, religion (including religious dress and grooming practices), sex, sexual orientation, gender, gender identity, gender expression, age, marital status, national origin, ancestry, citizenship status, pregnancy, medical condition, genetic information, mental and physical disability, political affiliation, union membership, status as a parent, military or veteran status or other non-merit based factors. We will provide reasonable accommodations throughout the application, interviewing and employment process. If you require a reasonable accommodation, contact your local branch. Advantage Technical is an E-Verify employer. This policy is applicable to all phases of the employment relationship, including hiring, transfers, promotions, training, terminations, working conditions, compensation, benefits, and other terms and conditions of employment.

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