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Manager Asq Cqa Jobs (NOW HIRING)

Fresenius Kabi

Manager, Quality Systems

Warrendale, PA · On-site

$115K - $130K/yr

In addition, the Manager, Quality Systems will represent the local quality system in global and ... ISO 9001/13485 lead auditor, ASQ CQA, etc.). * Experience dealing directly with FDA inspectors and ...

Merz North America, Inc.

ASQ CQA or CMQ/OE Technical & Functional Skills * Knowledge of regulatory requirements for medical ... Adobe; and Quality System Management Software. * Familiar with ISO 13485 Quality System Standards ...

Freseniusglobal

Manager, Quality Systems

Warrendale, PA · On-site

$115K - $130K/yr

In addition, the Manager, Quality Systems will represent the local quality system in global and ... ISO 9001/13485 lead auditor, ASQ CQA, etc.). * Experience dealing directly with FDA inspectors and ...

Amsted Rail Company Inc

Quality Manager

Granite City, IL · On-site

$110K - $130K/yr

ASQ CQA or CQE certification * Proficiency with Microsoft Office, especially Word and Excel * Excellent writing and verbal communication skills 12 ATTRIBUTES * Ensures accountability * Manages ...

Artivion

Quality Systems Engineer II

Kennesaw, GA · On-site

ASQ CQA/CQE/LSS and/or AATB CTBS or other auditing certification preferred. * Experience with electronic quality management systems and using QA software tools. * Strong analytical and problem ...

Artivion

Quality Systems Engineer I (Hybrid)

Austin, TX · Hybrid

ASQ CQA/CQE/LSS certification preferred. * Experience with electronic quality management systems and using QA software tools is preferred. * Strong analytical and problem-solving skills. * Excellent ...

Captek Softgel International

QA Supervisor

Vista, CA · On-site

Summary The QA Supervisor will work with and assist QA management in project management ... Working knowledge of cGMPs and FDA regulations ASQ CQA and/or CHA certification preferred The work ...

CryoLife

Quality Systems Engineer II

Kennesaw, GA · On-site

ASQ CQA/CQE/LSS and/or AATB CTBS or other auditing certification preferred. * Experience with electronic quality management systems and using QA software tools. * Strong analytical and problem ...

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Manager Asq Cqa information

What is a Manager ASQ CQA?

A Manager ASQ CQA is a management professional who holds the Certified Quality Auditor (CQA) credential from the American Society for Quality (ASQ). This certification validates expertise in auditing quality systems, processes, and procedures to ensure compliance and continuous improvement. A Manager ASQ CQA typically leads quality audit teams, develops audit strategies, and ensures organizational adherence to quality standards. Their role is essential in industries that prioritize regulatory compliance, risk management, and quality assurance.

What are the key skills and qualifications needed to thrive as a Manager ASQ CQA, and why are they important?

To thrive as a Manager with ASQ CQA credentials, you need a solid background in quality management systems, auditing processes, and regulatory compliance, typically supported by a bachelor’s degree and ASQ CQA certification. Familiarity with audit management software, statistical analysis tools, and standards like ISO 9001 is essential. Strong leadership, critical thinking, and effective communication skills help drive continuous improvement and foster teamwork. These competencies ensure high-quality operations, regulatory adherence, and successful audit outcomes for the organization.

How does a Manager ASQ CQA typically collaborate with cross-functional teams to ensure quality standards are met?

A Manager ASQ CQA (Certified Quality Auditor) frequently works with departments such as production, engineering, and regulatory compliance to uphold and improve quality management systems. They lead audit teams, facilitate communication between groups to address quality concerns, and guide corrective action efforts based on audit findings. This role requires strong interpersonal and project management skills to coordinate initiatives, ensure everyone understands quality standards, and drive continuous improvement across the organization. Regular meetings and detailed reporting are common practices to align team efforts with quality objectives.

What is the difference between Manager Asq Cqa vs Quality Assurance Supervisor?

AspectManager Asq CqaQuality Assurance Supervisor
CertificationsASQ CQA, Six Sigma, ISO AuditorTypically ASQ CQA or similar certifications
Work EnvironmentOversees multiple teams, strategic planningSupervises daily QA activities, team management
ResponsibilitiesDevelops quality systems, audits, process improvementsMonitors quality processes, reports issues, team oversight

The Manager Asq Cqa generally holds a higher strategic role, focusing on quality systems and audits across departments, while the Quality Assurance Supervisor manages daily QA operations and team supervision. Both roles require similar certifications but differ in scope and level of responsibility.

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Manager Asq Cqa jobs near you

Manager, Quality Systems

Warrendale, PA • On-site

Fresenius Kabi
Pharmaceutical and Medicine Manufacturing
Learn more about Fresenius Kabiexternal

$115K - $130K/yr

Full-time

Medical, Dental, Vision, Life, Retirement

Posted 14 days ago

Fresenius Kabi rating

8.3

Company rating: 8.3 out of 10

Based on 43 frontline employees who took The Breakroom Quiz

25th of 86 rated pharmaceutical

Job description

Job Summary
Salary Range: $115,000 to $130,000 Yearly + 10% Annual Target Bonus
This position is primary responsible for providing compliance oversight for local quality systems compliance and procedures for the Fresenius Kabi medical device production unit in Warrendale, PA. The position is responsible for reporting on the health of regulatory compliance and partnering with functional managers to develop and maintain scalable, compliant systems. In addition, the Manager, Quality Systems will represent the local quality system in global and divisional initiatives expected to impact the local quality system and host and facilitate effective third-party audits.
Responsibilities
1. Develops and delivers quality compliance strategy in alignment with global quality, divisional, production unit, and local and international regulations and standards.
2. Directly responsible for ongoing execution and improvements to the production unit's quality system activities, which includes, but not limited to: Corrective & Preventative Action, management controls, , complaint investigations, internal auditing, change control, and document control.
3. Monitors the performance of local quality systems and report to management periodically on compliance health, inspection readiness, and audit results.
4. Develops and implements a cross-functional internal audit program to ensure that all worldwide regulatory and global quality system requirements are implemented and met at the production unit.
5. Represents the local quality system during regulatory and external inspections.
6. Prepares and manages local regulatory and external audits, including post-audit activities.
7. Drives QMS initiatives throughout the organization.
8. Partners with and leads functional quality management to develop and maintain high performing, scalable and compliant quality systems.
9. Interacts with other Quality Units within Fresenius- Kabi Devices Division for resolution to compliance issues.
10. Provides leadership and guideance for effective and timely communication and appropriate escalation of quality system issues to all levels of the organization.
Please note: This position cannot provide employment-based immigration sponsorship now or in the future. Applicants must be currently authorized to work in the United States for any employer and must be able to maintain that authorization for the entire duration of employment without requiring employer sponsorship at any time, including in the instance when your current work authorization expires.
REQUIREMENTS
  • Bachelor's degree in a life science, engineering, physical science or related discipline.
  • 8 - 10 years of experience with in depth knowledge of the regulatory environment for medical devices for globally distributed products: 21 CFR Parts 11, 820, ISO 13485, ISO 14971,Quality systems expert with knowledge of QSR, ISO, MDD, CMDR, MDSAP and MEDDEV requirements. Ability to develop and manage Quality Systems in compliance with all applicable regulatory bodies.
  • Lead Auditor or ASQ professional certification highly desired (i.e. ISO 9001/13485 lead auditor, ASQ CQA, etc.).
  • Experience dealing directly with FDA inspectors and other regulators during quality system audits. Front Room Audit Experience preferred.
  • Communication and Influence: Clear, persuasive communication essential for explaining quality standards, presenting data, and influencing stakeholders at all levels.
  • The Company's primary business language is English. The successful candidate must be able to effectively speak, read, write, and understand English to perform the essential functions of the position, including independently understanding policies, procedures, training materials, and workplace communications written in English due to our heavily regulated work environment.
  • Team Development and Coaching: Effectively hires, develops, coaches, manages and motivates staff. Writes and administers performance appraisals.
  • Proven ability to use computer software and applications, including intermediate/advanced functions Microsoft Office (Word, Excel, PowerPoint and Access) and/or PC SAS or other analytical software packages, to share, retrieve, research and present business information.

Additional Information
We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company contribution, and wellness program.
Please note that joining our team does not create a guaranteed or permanent employment arrangement. All employment is at-will, meaning both the employee and Fresenius Kabi have the right to end the employment relationship at any time, in accordance with applicable federal and state laws.
Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.

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