Quality Assurance Systems Manager
Harleysville, PA
Full Time
Manager/Supervisor
If you are looking to make a difference and improve patients’ lives, then look no further…Come join the TEAM at MedComp!
Quality Assurance Systems Manager
Position Type: Onsite
*Only Local candidates within a reasonable commute distance will be considered as the position is based in Harleysville, PA.
Relocation: not available for this position
Sponsorship: not available for this position
Education: Bachelor’s degree in Engineering, Life Sciences, or a related field. Advanced degree preferred.
Experience: Minimum of 5 years of experience in quality assurance within the medical device industry.
Certifications: Certified Quality Auditor (CQA), Certified Quality Manager (CQM), or similar certifications preferred.
Skills: Strong knowledge of FDA regulations, ISO 13485, EU MDR, MDSAP country regulations and other relevant standards. Excellent analytical, problem-solving, and communication skills. Proficiency in quality management software and tools.
Personal Attributes:
- Detail-oriented with a strong focus on accuracy and compliance.
- Ability to work independently and as part of a team.
- Strong leadership and mentoring skills.
- Excellent organizational and time management skills.
- Ability to travel < 15% per year.
MedComp is a leading developer and manufacturer of vascular access products specializing in the field of interventional medicine, dialysis, and oncology. We are committed to providing innovative, quality products for hemodialysis, peritoneal dialysis, drainage, and infusion needs to positively impact the patients and clinicians who utilize them.
If you have been looking for a role where your contribution will matter, this is it. We will provide YOU with the opportunity to be part of a team that develops, enhances and supports products that truly make a difference in the life of the patients we serve.
How you’ll contribute:
The Quality Assurance Systems Manager leads the development, implementation, and maintenance of the Quality Manager System to ensure compliance with regulatory requirements and industry standards in the manufacturing of medical devices.
This role requires strong leadership, analytical, and communication skills, with a deep understanding of medical device regulations, quality system standards, and continuous improvement principles.
Essential Duties & Key Responsibilities:
- Standardize Quality Management Systems across multiple businesses, including establishing Corporate Policies, SOPs and the Quality manuals.
- Ensure continued compliance with FDA, ISO 13485, MDSAP countries, EU MDD &MDR requirements and other applicable regional and international regulations.
- Support preparation activities for and participate in regulatory inspections/external audits (Notified Body and Customers).
- Actively monitor processes for compliance with Corporate Policies, procedures, and relevant regulations.
- Subject Matter Expert (SME) for QMS processes.
- Identify and mitigate risks related to product quality and regulatory compliance.
- Analyze QMS process effectiveness and identify gaps or areas for improvement.
- Develop, monitor, maintain and report on Quality Key Performance Indicators (KPI).
- Identify compliance gaps and lead focused teams to resolve compliance issues.
- Provide recommendations for continuous improvements to Senior Management, support improvements of the QMS and other business processes as needed.
- Support New Product Development (NPD) initiatives.
- Lead and manage QMS functions: Change Control, CAPA, Document Management, NCR, Variances and others as applicable.
- Write and revise SOPs, controlled forms, and related documents to ensure best practices and compliance with the regulations.
- Prepare, Coordinate, and lead Quality Systems Management Review.
- Develop QMS training material and conduct training to improve employee understanding of the QMS and associated processes.
- Manage and mentor a team of quality assurance professionals.
- Support Distribution Center resolving potential nonconformances and improve processes.
- Perform other duties as assigned.
Directly supervise QA professionals at Martech and Medcomp locations, excluding Yuma location. Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws. Responsibilities include, approving/denying PTO requests, tracks PTO, interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.
Our offerings have our Team Members well-being in mind.
- Hybrid environment after six months – 4 days in office and 1 day remote
- Competitive compensation
- Health, Dental, Vision coverage
- FSA
- Life Insurance
- 401k
- Paid Holidays
- Generous PTO
What we live by:
VISION & MISSION STATEMENT
To be the leading solution provider for every customer we serve.
To drive sustainable growth of our business through the continued investment in our people, technology and quality while delivering world-class products and services.
We offer meaningful rewarding work to our team members by providing a culture that is built on and supported by practicing our core values, and by providing our team members with the tools and resources they need to succeed.
Respect Integrity Commitment Passion Collaboration Safety
We are committed to ensuring equal employment opportunities for all job applicants and employees. Employment decisions are based upon job-related reasons regardless of an applicant's race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, marital status, genetic information, protected veteran status, or any other status protected by law.
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