Oscor Inc. designs, manufactures, and markets a variety of highly specialized implantable cardiac pacing leads, venous access systems and diagnostic catheters. Oscor is proud to offer excellent career opportunities, great benefits and the ability to work as a team producing and delivering products which improve patients' lives.
The Quality Compliance Engineer supports quality excellence throughout the organization by promoting compliance to standard and regulations. The purpose of this position is to implement the Internal Audit to ensure that the quality management system is in compliance with the established quality management system requirements, applicable regulatory requirements, and to determine the effectiveness of the quality system. Internal audits are conducted at planned intervals to determine the effective implementation, adequacy and maintenance of the Quality Management System to identify non-conformances and opportunities for improvement. This role will also support customer audits and supplier quality audits.
Duties & Responsibilities:
Support Quality Compliance activities
Support Management Reviews activities and preparation
Support Customer Audits and host customer audits
Promote high standards of professionalism, ethics and compliance. Actively support our compliance program-related initiatives and activities.
Support site specific internal / external audit readiness activities.
Support CAPA investigations into potential quality/compliance concerns.
Work with Quality Assurance for a timely resolution of documentation requests from our customers.
Support EIA's and CAPAs investigation and CAPA phases approvals identified during Internal / External Audits
Support customers/Supplier's audits and regulatory body audits.
Support and participate the internal audits program activities.
Coordinate pre and post audit activities.
Interpret accurately the applicable regulatory standards i.e. (ISO13485, 21CFR Part 820, Canada Medical Device Regulations (Health Canada), MDD (European Council Directive 93/42/EEC Concerning Medical Devices), AIMD (European Council Directive 90/385/EEC Relating to Active Implantable, TG(MD)R Sch3 P1 1.4(5)(b)(iii), RDC ANVISA 16/2013: 7.3, MHLW MO169: 22, 23, 56, MDSAP)
Performs corrective action or preventive action effectiveness as required.
Bachelor of Science in Engineering, Quality or equivalent technical degree and/or experience
2-5 years' experience in the medical device industry with an understanding of FDA and/or ISO regulations preferred
2 - 4 years related QA Engineering experience in a cGMP environment
Knowledge of the regulatory standards ISO13485, 21CFR Part 820 and other international standards required
Experience in assisting routine internal, customer or regulatory body audits.
Ability to identify compliance issues.
Knowledge of the Engineering Change process
Strong proficiency in MS Office
Ability to communicate in a professional and courteous manner with clients
Excellent analytical problem solving skills
Excellent communication and presentation skills
Must be able to work as a team to gather information needed to understand and solve problems
Certified auditor is a plus
Oscor has a rewarding benefits program with a generous amount of PTO as well as paid holidays, medical, dental, and vision insurance, company paid short term and long term disability, as well as 401K partial match
Oscor Inc. is an Equal Opportunity Employer and a Drug Free Workplace