Quality Assurance Manager & Regulatory Affairs (Medical)
Company: OSI Systems
Posted on: June 12, 2021
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.
- Serve as Management Representative for OSI Optoelectronics
- 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
- 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,
- 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
- Lead all regulatory responses, including internal actions and
- 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)
- 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.
- 5-7 years of broad QARA and medical device industry experience
- 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
- Ability to manage multiple, complex priorities within demanding
- 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
- 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
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
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