Quality Assurance Manager & Regulatory Affairs (Medical)

Company: OSI Systems
Location: Hawthorne
Posted on: June 12, 2021

Job Description:

Overview

OSI Systems companies have a long history of developing innovative solutions to bring a better quality of life to the world. Healthcare, security and defense are among the key markets where we have made significant inroads with new ideas, products and processes. We know that many people live in difficult and dangerous conditions. To improve these circumstances, experts need simple, effective tools utilizing the latest in technology.

As a global company, we are dedicated to developing these tools for our customers and the people they serve worldwide. Our singular focus is to help security experts, clinical professionals and high-tech developers solve real-world problems and issues.

Our OSI Optoelectronics division is a diversified manufacturer of electronic devices and value-added manufacturing services for use in a broad range of applications, including aerospace and defense electronics, security and inspection systems, and medical monitoring and diagnostics. OSI Optoelectronics is seeking a Quality Assurance Manager and Regulatory Affairs, Medical to join their team. This individual will be responsible for the medical device quality assurance and regulatory affairs for OSI Optoelectronics medical products across multiple product areas, manufacturing facilities and product design locations. They will ensure compliance with all medical device related regulations applicable to OSI Optoelectronics, in the U.S. as well as elsewhere around the world.

They will lead all QARA functions, including regulatory registration, CAPA management, audit preparation and response management, manufacturing quality review, documentation, and records. Primary expectations include a comprehensive quality management system, delivering compliance to regulatory requirements and needs for reliable medical device design and manufacturing. Must lead a global company culture of continuous improvement, rigorous discipline around specs and procedures, and implementation of tight controls. This role requires global thinking and cross-functional collaboration and hands-on action.

Responsibilities

• Serve as Management Representative for OSI Optoelectronics (Medical).
• Partner with various functions to assure quality of OSI Optoelectronics products and services.
• Assure compliance with all medical device regulations applicable to OSI Optoelectronics and manage relationships with regulatory and standards-setting bodies.
• Requires substantial experience with and knowledge of medical device regulations, including US FDA, EU, Health Canada, and UK, and the Medical Device Single Audit Program (MDSAP).
• Strong experience with risk management and electrical safety standards, including ISO 14971 and IEC 60601.
• Will work with OEM and Private Label (PLM) customers, design control, and manufacturing.
• Will work with implementation and managing labeling and IFU requirements.
• Work with US FDA 510(k)'s, Canada device submissions, and EU and UK Technical Documentation Files.
• Experience with US FDA and EU UDI requirements, implementation, and maintenance.
• Determine strategy and requirements for entering global markets. Work closely with R&D, Operations and Legal to ensure that country-specific regulatory and registration requirements are met during the product life cycle.
• Prepare the organization for compliance audits (FDA and EU Notified Body), with appropriate training, mindset, roles, and internal audits.
• Lead all regulatory responses, including internal actions and follow-up.
• Ensure appropriate quality measurements and metrics are developed for all areas affecting product quality, to ensure monitoring and alerting quality deviations.
• Manage appropriate investigation and response processes with the goal of continuous improvement.
• Develop and support the management company's QARA (Medical) budget.
• Coordinates and assists with site initiatives, participating on teams in order to drive best practices.
• Uphold the company's core values of Integrity, Innovation, Accountability, and Teamwork.
• Demonstrate behavior consistent with the company's Code of Ethics and Conduct.
• It is the responsibility of every employee to report to their manager or a member of senior management any quality problems or defects in order for corrective action to be implemented and to avoid recurrence of the problem.
• Duties may be modified or assigned at any time to meet the needs of the business.

Qualifications

• 5-7 years of broad QARA and medical device industry experience required.
• Bachelor's degree preferably in engineering or science, or related field required.
• Knowledge and experience with ROHS3, REACH, TCPA, and California Proposition 65.
• Ability to articulate a vision and strategy to inspire and motivate; and know how to implement strategy to achieve goals. Can present an effective and consistent message to employees and key partners.
• Ability to manage multiple, complex priorities within demanding timeframes.
• Success in the design and management of world-wide regulatory compliance programs; record of positive interactions with medical device regulators and standards-setting bodies.
• Untarnished reputation for personal and professional integrity and honesty. Assertive professional style with outstanding leadership skills.
• Able to implement change initiatives and deliver results through others, both direct and matrixed.
• A creative and innovative individual, with the ability to simplify, communicate and sell ideas across the organization and with external contacts.
• Excellent communication and negotiation skills, both internal and external, at all levels.

NOTICE TO THIRD PARTY AGENCIES

OSI Systems, Inc. and its subsidiaries (collectively "OSI") does not accept unsolicited resumes from recruiters or employment agencies. If any person or entity, including a recruiter or agency, submits any information, including any resume or information regarding any potential candidate, without a signed agreement in place with OSI, OSI explicitly reserves the right to use such information, and pursue and/or hire such candidates, without any financial obligation to the person, recruiter or agency. Any unsolicited information or resumes, including those submitted directly to hiring managers, are considered and deemed to be the property of OSI.

Equal Opportunity Employer - Disability and Veterans

EEO is the Law

Poster Link: https://www.eeoc.gov/sites/default/files/migrated_files/employers/eeoc_self_print_poster.pdf

OSI Systems, Inc. has three operating divisions: (a) Security, providing security and inspection systems, turnkey security screening solutions and related services; (b) Healthcare, providing patient monitoring, diagnostic cardiology and anesthesia systems; and (c) Optoelectronics and Manufacturing, providing specialized electronic components and electronic manufacturing services for original equipment manufacturers with applications in the defense, aerospace, medical and industrial markets, among others.

Keywords: OSI Systems, Hawthorne , Quality Assurance Manager & Regulatory Affairs (Medical), Other , Hawthorne, California