Job summary
Job post source
This job is directly from Medical Components, Inc.
Job overview
The Quality Assurance Systems Manager at Medical Components, Inc. leads the development and maintenance of the Quality Management System to ensure regulatory compliance and quality in medical device manufacturing, impacting patient care positively.
Responsibilities and impact
The role involves standardizing QMS across businesses, ensuring compliance with FDA and international regulations, leading audits, managing QMS functions, mentoring QA professionals, supporting new product development, and continuous improvement of quality processes.
Compensation and benefits
The position offers competitive compensation, health, dental, vision coverage, FSA, life insurance, 401k, paid holidays, generous PTO, and a hybrid work environment after six months.
Experience and skills
Requires a bachelor's degree in Engineering or Life Sciences, 5+ years in medical device quality assurance, knowledge of FDA, ISO 13485, EU MDR, MDSAP, and preferred certifications like CQA or CQM, plus strong analytical, leadership, and communication skills.
Career development
Opportunities include leading quality teams, influencing corporate policies, supporting new product development, and continuous improvement initiatives within a growing medical device company.
Work environment and culture
The company culture emphasizes respect, integrity, commitment, passion, collaboration, and safety, with a supportive environment focused on employee growth and equal opportunity.
Company information
Medical Components, Inc. is a leading developer and manufacturer of vascular access products for interventional medicine, dialysis, and oncology, committed to innovative, quality products that improve patient outcomes.
Team overview
The manager will supervise QA professionals at multiple locations except Yuma, handling hiring, training, performance appraisals, and team leadership.
Job location and travel
The position is onsite in Harleysville, PA, with a hybrid work option after six months and less than 15% travel required.
Unique job features
This role uniquely combines leadership in quality assurance with direct impact on life-saving medical devices, offering involvement in regulatory compliance, product development, and cross-business QMS standardization.
Company overview
Medical Components, Inc. (often known as Medcomp) is a leading manufacturer specializing in the design and production of vascular access devices and related medical components, serving hospitals, clinics, and healthcare providers worldwide. The company generates revenue by supplying products like catheters, ports, and introducers used in critical care, dialysis, and interventional procedures, with a focus on innovation and regulatory compliance. Founded in 1978 and headquartered in Harleysville, Pennsylvania, Medcomp has established a reputation for quality, reliability, and ongoing product development. Its growth has been driven by advancements in medical technology and a strong commitment to customer service and education. Candidates should be aware of Medcomp's emphasis on clinical excellence, patient safety, and its significant role in the global medical device industry.
How to land this job
Position your resume to emphasize your expertise in quality assurance within the medical device industry, highlighting your knowledge of FDA regulations, ISO 13485, EU MDR, and MDSAP standards to align with Medical Components, Inc.'s compliance needs.
Highlight leadership experience managing quality assurance teams and your ability to develop, implement, and maintain Quality Management Systems, including SOP creation, audit preparation, and KPI monitoring.
Apply through multiple channels such as Medical Components, Inc.'s corporate careers page and LinkedIn to maximize your application visibility for the Quality Assurance Systems Manager role.
Connect with current employees in the quality assurance or regulatory affairs divisions at Medical Components, Inc. on LinkedIn; use ice breakers like complimenting recent company product innovations or asking about their experience with regulatory inspections to start meaningful conversations.
Optimize your resume for ATS by incorporating keywords from the job description such as 'Quality Management System,' 'CAPA,' 'Change Control,' 'FDA compliance,' 'ISO 13485,' and 'regulatory audits' to ensure your resume passes automated screenings.
Use Jennie Johnson's Power Apply feature to automate tailored resume submissions, identify optimal application portals, and find LinkedIn contacts to network with, freeing up your time to prepare for interviews and further research the company.
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