QMS Manager
Joulé
Quakertown, PA
Location: Quakertown (On-site)
Schedule: M-F 8 am-5 pm
Type: Direct/Permanent
Target Salary Range: $145,000 to $160,000 + 15% bonus
Start date: Immediate
Are you ready to take the next step in your quality management career? We are looking for a passionate and results-driven Quality Management Systems Manager to lead our CAPA processes, manage audits, and collaborate with regulatory bodies to ensure our products meet the highest standards. In this pivotal role, you’ll have the opportunity to own and enhance our QMS while driving continuous improvement across the organization. If you thrive in a fast-paced, medical device environment and excel in solving complex challenges, we want to hear from you!
Responsibilities:
- Lead CAPA processes, including root cause analysis, corrective/preventive actions, and timely resolution of quality issues.
- Hosting audits including but not limited to supplier, internal, and external audits, ensuring compliance with FDA, ISO 13485, and MDR standards.
- Notify regulatory bodies of significant changes and maintain readiness for audits and inspections.
- Oversee the implementation and maintenance of the Quality Management System (QMS) to ensure alignment with regulatory requirements specific to medical devices.
- Collaborate with cross-functional teams to address quality issues and enhance product compliance.
- Manage document control systems, including the creation, revision, and approval of SOPs and quality records.
- Conduct risk assessments and implement risk mitigation strategies as part of the quality planning process.
- Ensure proper training and competency for employees on quality policies, procedures, and best practices.
- Identify opportunities for process improvements and lead quality-related training programs to enhance organizational competence.
- Prepare and maintain accurate records, reports, and updated SOPs related to CAPA and audits.
Requirements:
- Bachelor’s Degree required.
- Minimum of 10 years of experience within the medical device, pharmaceutical, or medical manufacturing industries.
- In-depth knowledge of CAPA processes, internal and external audits, and regulatory requirements (e.g., FDA, ISO 13485).
- Strong problem-solving skills with experience in root cause analysis and risk management.
- Familiarity with quality management software is required; experience with TrackWise is preferred but not essential.
#M3
#LI-MD1
Ref: #558-Scientific
About the Company
Joulé
Our Story
Impacting lives. It's in our DNA.
At Joulé, we believe our world is filled with possibilities – where character, integrity and commitment drive our purpose. For over 30 years, Joulé has been a trusted partner to industry leading clinical, scientific, and healthcare organizations by providing innovative workforce solutions and delivering top talent. Operating at the forefront of the life sciences arena, Joulé’s relentless approach enables our clients to rapidly and effectively execute critical initiatives and major projects. Joulé is a System One division.
Joulé consists of multiple business lines working together for client success: scientific, clinical, and healthcare recruiting plus equipment services.
Since our existence, we’ve excelled in these specialized markets, and in recent years we have further narrowed the Joulé brand to exclusively represent these arenas. Joulé's services are backed by the considerable reach and resources of our parent company, System One.
The Business of Science
Way back before STEM was a trend, Joulé established its roots in scientific and technical disciplines. We began life as an engineering services firm, but our business has evolved considerably to where it stands today:
- A leader in specialized workforce solutions and integrated services
- One of the top ten largest clinical and scientific staffing firms in the U.S.
- An ISO-certified provider of laboratory and facility support
- An advocate for scientific, clinical, and healthcare clients and candidates alike
National Reach with Local Expertise
Working at the intersection of business and science, we make it easier to recruit and deploy talent for ongoing work and on-demand projects in a host of disciplines. We’re still writing our story, but our future is built on a foundation of quality delivery and personalized service.