Sr. Quality Assurance Specialist - On Site (Harleysville, PA)

Quality Assurance Specialist I - On Site (Harleysville, PA)Qualifications - Bachelor's degree in engineering, life sciences, or related field preferred.Minimum 8 plus years' managing and implementing related Quality Assurance processes within Medical Device or other regulated industry; or equivalent combination of education and experience.Working knowledge and in-depth understanding of Medical Device regulations (FDA 21CFR820, ISO 13485, EU MDR)Experience implementing and managing Quality Management System processes.Quality certifications (e.g ASQ Certified Quality Auditor or Engineer) a plus. Excellent analytical skills, able to solve complex problems and make data-driven decisions. Effective communication and interpersonal skills with the ability to collaborate across functional teams.What you will be responsible for: The Sr. QA Specialist will be involved in training QA Associates as well as act as a liaison between the QA team and other departments (Engineering, Production, Materials, etc.). They will manage quality assurance processes to ensure the company's products are of the highest quality and are developed, produced, controlled and distributed according to the requirements of established organizational policies and procedures, regulations of the FDA, ISO 13485, the MDD, EU Medical Device Regulation (2017/745) Canadian Medical Device Conformity Assessment System and other applicable country regulations and standards.How you will contribute:Reviews and approves Device History Records (DHR) and inspection records to support release of product. Manage the internal audit program Creates and manages annual internal audit scheduleSchedule and coordinate internal audits with appropriate departments, subject matter experts, and internal auditors. Conducts internal audits and manages timely completion in accordance with the established schedule. Manages the timely completion of internal audit findings with departments owners/Auditee Support external audits through preparation activities, coordination of individuals, documents and records.Represents the organization on behalf of QA with external partners to communicate QA policy and procedures; liaise with external partners and provide input on regulatory communications Reviews, manages and approves Change Control Document(s) according to the priorities of the business. Conducts Quality System Change Review evaluations for significant changes impacting the QMS. Submit significant changes to the notified body. Establishes, monitors, and manages Key Performance Indicators (KPIs)Manages, compiles and reviews load release documentation with Sterilization and Quality Control. Coordinate and support preparation of data for Management Review and other Quality Presentations / data collection as needed. Data trending (tracking and analyzing) and reporting. Evaluates, investigates and approves non-conformance (NCR) and CAPA investigations and documents. Determines corrective actions needed and analyzes the corrective actions taken by personnel to ensure product safety and release. Assists with corrective action and preventive action implementation through closure. Manages and leads root cause and corrective actions investigations for External Supplier Corrective Action requests according to customer outlined timeframes. Reviews, revises or creates new procedures/instructions for the Quality System. Coordinates across departments to resolve and eliminate quality issues, including documentation observations. Facilitate good documentation practices throughout the facility. Coach and train QA Associates Review and approve IQ/OQ/PQ for equipment, instruments, or facilities.Review and approve engineering testing protocols and summaries. Compiles certificate of conformance as needed. Supports and manages Engineering Test samples as needed.Develop training materials related to processes managed (ie: Internal Audit), or as needed, in support of promoting Quality System process requirement awareness. Lead continuous improvement initiatives as assigned. Complete ad-hoc tasks, as assignedAbout Us - Medcomp® develops, manufactures, markets, and supports cutting-edge vascular access devices and accessories to meet the clinical needs of the medical industry, particularly in the fields of interventional medicine and dialysis. Our company's engineering and applications expertise provides superior products whose progressive designs accommodate advances in medicine and whose quality anticipates the requirements of our professional clients and the patients they serve. Currently one of the world's largest manufacturers of dialysis and centrally terminating venous catheters, Medcomp is, and always has been, on the cutting edge of new vascular access device technologies.Our offerings have our Team Members' well-being in mind.Competitive compensationHealth, Dental, Vision coverageFSALife Insurance401kPaid HolidaysGenerous PTOWhat you will get from us:VISION & MISSION STATEMENTTo 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. 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.