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Contractual Quality Engineer Fda Jobs in Indiana

CTE Solutions

Supplier Quality Engineer

Plymouth, IN · On-site

... and contractual requirements. * Document supplier audit findings and work with suppliers and ... Collaborate with internal Quality and Engineering teams to determine appropriate validation ...

EHOB INC

Quality Assurance Engineer

Indianapolis, IN · On-site

Summary The Quality Assurance Engineer will support the organization towards compliance of ... Ensure compliance with FDA, ISO 13485, and other relevant regulatory standards for medical device ...

Reveille Technologies

Quality EngineerWarsaw, IN

Warsaw, IN · On-site

$69K - $89K/yr

Ability to read and understand engineering drawings * Knowledge of Quality System requirements, ISO and FDA requirements (preferred) * Ability to effectively work within a team to expedite completion ...

Reveille Technologies

Quality EngineerWarsaw, IN

Warsaw, IN · On-site

$69K - $89K/yr

Ability to read and understand engineering drawings * Knowledge of Quality System requirements, ISO and FDA requirements (preferred) * Ability to effectively work within a team to expedite completion ...

AM General

Mgr Quality Engineering I

Mishawaka, IN

$66K - $85K/yr

Establish and maintain Product Quality Standards in compliance with customer, contractual ... Lead APQP planning, validation, and execution for new programs and engineering changes, including ...

AM General

Mgr Quality Engineering I

Mishawaka, IN · On-site

$66K - $85K/yr

Establish and maintain Product Quality Standards in compliance with customer, contractual ... Lead APQP planning, validation, and execution for new programs and engineering changes, including ...

AM General LLC

Mgr Quality Engineering I

Mishawaka, IN · On-site

$66K - $85K/yr

Establish and maintain Product Quality Standards in compliance with customer, contractual ... Lead APQP planning, validation, and execution for new programs and engineering changes, including ...

CYNET SYSTEMS

Operations Quality Principal

Indianapolis, IN · On-site

$64 - $67/hr

Strong hands-on engineering proficiency with enterprise data science environments (such as Dataiku ... Sound understanding of GxP compliance, US FDA 21 CFR Part 820 Quality Management System Regulations ...

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All JobsContractual Quality Engineer Fda JobsContractual Quality Engineer Fda Jobs in Indiana

Contractual Quality Engineer Fda information

What is the difference between Contractual Quality Engineer Fda vs Contract Quality Engineer?

AspectContractual Quality Engineer FdaContract Quality Engineer
CertificationsISO 13485, FDA regulations, GMPISO 13485, FDA regulations, GMP
Work EnvironmentMedical device manufacturing, regulated environmentsMedical device, pharmaceutical, or biotech industries
Employer UsageContract roles for FDA-regulated companiesContract roles across various industries including pharma and biotech
Search IntentCompare FDA-specific quality rolesBroader quality contract roles in regulated industries

The Contractual Quality Engineer Fda focuses specifically on FDA regulations and medical device compliance, often working in regulated environments. The Contract Quality Engineer has a broader scope, covering various industries like pharma and biotech, with similar certifications. Both roles require knowledge of FDA standards, but the Contractual Quality Engineer Fda emphasizes FDA-specific compliance in medical devices.

What are the most commonly searched types of Quality Engineer Fda jobs in Indiana?

The most popular types of Quality Engineer Fda jobs in Indiana are:

What cities in Indiana are hiring for Contractual Quality Engineer Fda jobs?

Cities in Indiana with the most Contractual Quality Engineer Fda job openings:

Contractual Quality Engineer Fda jobs near you

Supplier Quality Engineer

Culver Tool and Engineering LLC

Plymouth, IN • On-site

Full-time

Medical, Dental, Vision, Life, Retirement, PTO

Posted 5 days ago

Job description

Build More Than a Job-Build a Career at SpiTrex CTE
At SpiTrex CTE, we invest in our people. You'll find opportunities to grow, real flexibility, and a culture that values balance, development, and teamwork.
Why join CTE?
  • Career Growth: Ongoing training and development through Bamboo Path Track & Litmos
  • Flexibility: Flextime options that support real life
  • Culture: Team events, Donut Fridays, food trucks, and more
  • Rewards: Referral bonuses, quarterly bonuses, and a 401(k) with 50% company match (up to 10%)
  • Benefits: No-cost vision, life, and short-term disability; dental & medical with HSA or PPO options

Ready to grow with a company that values you? Join SpiTrex CTE.
This position would be able to work remotely.
1st Shift: Monday to Thursday, 6:30AM - 3:30PM; Friday, 6:30AM - 10:30AM
Essential Functions:
  • Lead and maintain the organization's supplier quality management program in alignment with applicable quality system and regulatory requirements.
  • Develop, implement, and maintain processes for supplier qualification, approval, monitoring, and ongoing performance management.
  • Conduct supplier risk assessments and develop appropriate mitigation strategies based on supplier capability, quality history, criticality, and business risk.
  • Lead supplier qualification, onboarding, evaluation, and approval activities in partnership with Procurement and internal stakeholders.
  • Plan and conduct supplier quality audits and assessments to evaluate compliance with applicable quality standards, specifications, procedures, and contractual requirements.
  • Document supplier audit findings and work with suppliers and internal stakeholders to ensure timely and effective resolution.
  • Manage supplier corrective action requests (SCARs), including investigation, root cause analysis, corrective action development, implementation, and verification of effectiveness.
  • Investigate supplier-related quality concerns and coordinate appropriate containment, disposition, and corrective action activities.
  • Provide technical support for supplier-related nonconformances, defects, and quality issues, including root cause and problem-solving activities.
  • Review and assess supplier change notifications to determine potential impacts to product quality, manufacturing processes, regulatory requirements, and business operations.
  • Collaborate with internal Quality and Engineering teams to determine appropriate validation, qualification, inspection, or other actions associated with supplier changes.
  • Develop and maintain supplier scorecards and performance metrics, including quality, delivery, responsiveness, corrective action, and other applicable measures.
  • Analyze supplier quality data and trends to identify recurring issues, emerging risks, and opportunities for improvement.
  • Partner with Procurement on supplier selection, qualification, performance evaluations, and supplier development activities.
  • Support incoming quality inspection and receiving functions by providing technical guidance and problem-solving assistance for supplier-related issues.
  • Participate in cross-functional investigations, CAPA activities, continuous improvement initiatives, and quality improvement projects.
  • Prepare supplier quality reports, metrics, and trend analyses for leadership and management review.
  • Establish and maintain effective working relationships with suppliers and internal stakeholders to promote accountability, communication, and continuous improvement.
  • Provide guidance and technical support to internal teams regarding supplier quality requirements and expectations.
  • Support special projects, strategic quality initiatives, and other duties as assigned
  • Conform to ISO13485, 21 CFR Part 820, and medical device industry requirements
  • Other work-related tasks as assigned

Competency:
  • Strong knowledge of supplier quality management principles and quality engineering practices.
  • Strong analytical and problem-solving skills with the ability to identify root causes and develop sustainable solutions.
  • Ability to interpret engineering drawings, specifications, inspection requirements, and other technical documentation.
  • Ability to effectively assess supplier capability, process controls, and quality risks.
  • Strong project management and organizational skills.
  • Ability to influence and collaborate across functional teams without direct authority.
  • Strong interpersonal and relationship-building skills with both internal and external stakeholders.
  • Ability to communicate complex technical and quality requirements clearly and effectively.
  • Demonstrated attention to detail and commitment to product quality and customer requirements.
  • Proficiency with Microsoft Office applications and quality management systems.

Educational Requirements:
A.S. in Engineering field preferred or minimum of 2 years in Quality Engineering role
Experience:
Medical Device manufacturing preferred
3 - 5 years of experience in Quality setting preferred
Benefits Include:
  • Medical, Vision and Dental Insurance
  • Short-Term Disability
  • Life Insurance
  • 401(k) - 50% company match (up to 10% contribution)
  • Paid vacation days
  • Paid holidays

Apply