Head of Compliance Operations
7 days ago
OnsiteAre you looking for a company that cares about people's lives and health, including yours? Olympus, a leading medical technology company, has focused on making people's lives better for over 100 years.
Job DescriptionThe Director of Quality, San Jose Operations is responsible for GMP Operations of the facility inclusive of manufacturing quality, repair quality, distribution quality, quality inspection and quality systems.
This role will ensure quality systems and processes are established, maintained, and continuously improved to consistently deliver right first-time quality, safeguard patient safety, and ensure customer satisfaction.
The Director of Quality will ensure that sethe site is inspection ready at all times, manage and facilitate site audits and inspections, lead execution of commitments to regulators, and ensure that quality and/or compliance issues are corrected in a timely manner.
This role will lead site initiatives aimed at building and sustaining a strong culture of quality and will work collaboratively with other functions at the site to achieve quality and business objectives.
This position serves as the default Quality Management Representative for the San Jose site.This position reports into the Quality organization directly and also reports indirectly to Top Management at the San Jose site.
Job DutiesLeadership of the Site Quality organization and serves as site quality management representativeensuring efficient and flawless execution of quality systems and processes to ensure product quality and compliance with global and site policies and procedures, FDA regulations, and other applicable regulations, standards and guidance.
In accordance with established budget, builds organizational capability and capacity to meet both the current and future needs of the business through talent acquisition, employee training / development and performance management.
Directs activities to ensure that the site is in a continued state of compliance and inspection readiness including analysis and evaluation of data and presentation to senior management to ensure that projects are appropriately prioritized in alignment with regulatory requirements and business goals.
Hosts external regulatory inspections and audits and ensures successful outcomes through inspection readiness activities, inspection management and observations resolution.Promotes awareness of regulatory requirements and expectations and ensures understanding of quality system requirements across the site. Identifies site training needs and leads efforts to ensure effective training delivery.
In accordance with quality system and technical requirements and risk management documents, ensures implementation of effective process controls for manufacturing, servicing and supply chain operations that support timely delivery of products that consistently conform to their specifications.
This includes validation and maintenance of the Site Master Validation Plan, calibration, equipment maintenance, critical component evaluations, and quality inspections.
Anticipates and identifies quality and compliance risks and proactively collaborates with Operations and Supply Chain leaders to identify potential areas of process and product variability.
Implements controls to prevent escape of nonconforming product, drives timely and thorough root cause investigations for quality issues (e.g., NCs, customer complaints), and ensures implementation of effective corrective and preventive actions (CAPA) to mitigate recurrence of quality problems.
Acts with appropriate levels of urgency commensurate with risk and escalates issues to management.Lead complex investigations to identify causes of problems to safeguard patient safety and business continuity.
Utilizes data to assess the overall health and effectiveness of the site's quality system and processes and identifies areas to improve efficiency and effectiveness.
Maintains budgetary oversight for the Site Quality Operations organization.Partners with Finance and Operations business partners to ensure that expenses, headcount and capital are in alignment with business goals, financial targets and strategic plans.
Engage in a positive manner with team members from all disciplines to enhance the culture of quality and maintain a patient and customer focused quality mindset.
A minimum of 10 years of cGMP experience in quality management (with direct shop floor experience) within the MedTech industry.
Experience with durable medical devices, and a strong understanding of repair operations and servicing requirements to ensure they continue to meet safety and performance specifications over their usable life.
Demonstrated experience influencing senior level management and key stakeholders and leveraging cross-functional partnerships for successful execution of critical quality initiatives.
Experience interpreting and applying business requirements and regulations (FDA and other applicable global authorities) into sustainable quality processes leveraging industry best practices.
Preferred:
Advanced technical degree and/or MBA preferred.
Lean Six Sigma Black Belt Certification desired.
Proactive approach to quality and compliance, with a focus on innovation and adaptation in a fast-paced environment.
Strong ability to think and act globally, be fearless change agent while managing risks, develop future visions and engage audiences to drive transformation.
Capable of presenting clear and insightful thoughts based in facts and data gain trust, build confidence and to influence key stakeholders across the business.
Competitive salaries, annual bonus and 401(k)* with company matchComprehensive Medical, Dental, Visions coverage effective on start date24/7 Employee Assistance ProgramFree virtual live and on-demand wellness classesWork-life balance supportive culture with hybrid and remote roles12 Paid HolidaysEducational AssistanceParental Leave and Adoption AssistanceVolunteering and charitable donation match programsDiversity & Inclusion Programs including Colleague Affinity NetworksOn-Site Child Daycare, Café, Fitness Center
US OnlyLimited locations We care about your health and financial well-being and offer the resources you need to feel vital, confident and ready for wherever life takes you.
About us:
Our Medical business uses innovative capabilities in medical technology, therapeutic intervention, and precision manufacturing to help healthcare professionals deliver diagnostic, therapeutic, and minimally invasive procedures to improve clinical outcomes, reduce costs, and enhance the quality of life for patients and their safety.
Olympus Corporation of the Americas, a wholly owned subsidiary of Olympus Corporation, is headquartered in Center Valley, Pennsylvania, USA, and employs more than 5,200 employees throughout locations in North and South America.
Olympus is dedicated to building a diverse, inclusive and authentic workplaceWe recognize diversity in people, views and lifestyle choices and emphasize the importance of inclusion and mutual respect.
It is the policy of Olympus to extend equal employment and advancement opportunity to all applicants and employees without regard to race, color, national origin (including language use restrictions), citizenship status, religious creed (including dress and grooming practices), age, sex (including pregnancy, childbirth, breastfeeding, medical conditions related to pregnancy, childbirth and/or breastfeeding), gender, gender identity and expression, sexual orientation, marital status, disability (physical or mental) and/or a medical condition, genetic information, ancestry, veteran status or service in the uniformed services, and any other characteristic protected by applicable federal, state or local law.
Applicants with Disabilities:
As a Federal Contractor, Olympus is committed to ensuring our hiring process is accessible to everyone.
If you need an accommodation in order to complete the application or hiring process, please contact Olympus via email at .
If your disability impairs your ability to email, you may call our HR Compliance Manager at 1-888-Olympus Posting Notes: || United States (US) || California (US-CA) || San Jose || Quality & Regulatory Affairs (QA/RA)-
Head of Compliance
1 month ago
San Francisco, California, United States Cardless Full timeAt Cardless, we're building a credit card and loyalty platform that consumer businesses use to engage their customers. We've launched 9 credit cards, including for the largest mall operator in the U.S. and the largest airline in South America. We help businesses bring imaginative card programs to life, and have pioneered technology to embed credit card...
-
Supervisory Compliance Investigator
3 weeks ago
San Francisco, California, United States Office Of Federal Contract Compliance Programs Full timeAlso advertised as job #MS-24-PHIL-OFCCP KG for Current Federal employees with competitive status; Former Federal employees with reinstatement eligibility; those eligible for ICTAP/CTAP within the local commuting area; eligible VEOA veterans; eligible Military Spouses; and eligible employees under the Land and Base Management Act. To be considered for each,...
-
Supervisory Compliance Investigator
4 weeks ago
San Francisco, California, United States Office Of Federal Contract Compliance Programs Full timeAlso advertised as job #MS-24-PHIL-OFCCP KG for Current Federal employees with competitive status; Former Federal employees with reinstatement eligibility; those eligible for ICTAP/CTAP within the local commuting area; eligible VEOA veterans; eligible Military Spouses; and eligible employees under the Land and Base Management Act. To be considered for each,...
-
Compliance Specialist
4 weeks ago
San Diego, California, United States Office Of Federal Contract Compliance Programs Full timeAlso advertised as job #MS-24-PHIL-OFCCP KG for Current Federal employees with competitive status; Former Federal employees with reinstatement eligibility; those eligible for ICTAP/CTAP within the local commuting area; eligible VEOA veterans; eligible Military Spouses; and eligible employees under the Land and Base Management Act. To be considered for each,...
-
Compliance Specialist
3 weeks ago
San Diego, California, United States Office Of Federal Contract Compliance Programs Full timeAlso advertised as job #MS-24-PHIL-OFCCP KG for Current Federal employees with competitive status; Former Federal employees with reinstatement eligibility; those eligible for ICTAP/CTAP within the local commuting area; eligible VEOA veterans; eligible Military Spouses; and eligible employees under the Land and Base Management Act. To be considered for each,...
-
Associate Head of School
6 days ago
San Jose, California, United States Spring Education Group Full timeBASIS Independent Schools (#5003), 1290 Parkmoor Ave, San Jose, California, United States of America Req #5536 Tuesday, May 14, 2024 BASIS Independent Schools, a subsidiary of Spring Education Group, is a national network of PreK-12 private, secular schools that educate students to the highest international levels. Our ten campuses, located in some of the...
-
Vehicle Patrol Supervisor
7 days ago
San Jose, California, United States Hammer Head Protection Inc Full timeABOUT US:It's not just about what WElook for in an employee, it's about what YOUlook for in an employer. Hammer Head Security is a family owned and military friendly security services firm based out of Stockton, CA and provides armed, unarmed, patrol, personal protection and event security services throughout the Central Valley, Sacramento Region, and Bay...
-
Supervisory Compliance Investigator
3 weeks ago
San Francisco, California, United States Office Of Federal Contract Compliance Programs Full timeAlso advertised as job #MS-24-PHIL-OFCCP KG for Current Federal employees with competitive status; Former Federal employees with reinstatement eligibility; those eligible for ICTAP/CTAP within the local commuting area; eligible VEOA veterans; eligible Military Spouses; and eligible employees under the Land and Base Management Act. To be considered for each,...
-
Supervisory Compliance Investigator
4 weeks ago
San Francisco, California, United States Office Of Federal Contract Compliance Programs Full timeAlso advertised as job #MS-24-PHIL-OFCCP KG for Current Federal employees with competitive status; Former Federal employees with reinstatement eligibility; those eligible for ICTAP/CTAP within the local commuting area; eligible VEOA veterans; eligible Military Spouses; and eligible employees under the Land and Base Management Act. To be considered for each,...
-
Head Varsity Water Polo Coach
3 weeks ago
San Jose, California, United States SISTERS OF THE PRESENTATION PRESENTATION HIGH SCHO Full timeDescription:Presentation High SchoolJob Classification: StaffPosition Title: Head Varsity Water Polo Coach Full-time/Part-time: Part-timeSalary: $5,750-$7,750 per seasonClassification: Exempt Reports to: Athletic DirectorSupervises: Assistant Water Polo CoachesAbout Presentation High School:Presentation High School is an independent Catholic college...
-
Head Varsity Water Polo Coach
3 weeks ago
San Jose, California, United States SISTERS OF THE PRESENTATION PRESENTATION HIGH SCHO Full timeDescription:Presentation High SchoolJob Classification: StaffPosition Title: Head Varsity Water Polo Coach Full-time/Part-time: Part-timeSalary: $5,750-$7,750 per seasonClassification: Exempt Reports to: Athletic DirectorSupervises: Assistant Water Polo CoachesAbout Presentation High School:Presentation High School is an independent Catholic college...
-
Head Varsity Water Polo Coach
4 weeks ago
San Jose, California, United States SISTERS OF THE PRESENTATION PRESENTATION HIGH SCHO Full timeDescription:Presentation High SchoolJob Classification: StaffPosition Title: Head Varsity Water Polo Coach Full-time/Part-time: Part-timeSalary: $5,750-$7,750 per seasonClassification: Exempt Reports to: Athletic DirectorSupervises: Assistant Water Polo CoachesAbout Presentation High School:Presentation High School is an independent Catholic college...
-
Head Varsity Water Polo Coach
7 days ago
San Jose, California, United States SISTERS OF THE PRESENTATION PRESENTATION HIGH SCHO Full time: Presentation High School Job Classification: Staff Position Title: Head Varsity Water Polo Coach Full-time/Part-time: Part-time Salary: $5,750-$7,750 per season Classification: Exempt Reports to: Athletic Director Supervises: Assistant Water Polo Coaches About Presentation High School: Presentation High School is an independent Catholic college...
-
Head Varsity Water Polo Coach
4 weeks ago
San Jose, California, United States SISTERS OF THE PRESENTATION PRESENTATION HIGH SCHO Full timeDescription:Presentation High SchoolJob Classification: StaffPosition Title: Head Varsity Water Polo Coach Full-time/Part-time: Part-timeSalary: $5,750-$7,750 per seasonClassification: Exempt Reports to: Athletic DirectorSupervises: Assistant Water Polo CoachesAbout Presentation High School:Presentation High School is an independent Catholic college...
-
Head of Finance
3 weeks ago
San Francisco, California, United States Twelve Labs Full timeWho we areAt Twelve Labs, we are pioneering the development of cutting-edge multimodal foundation models that have the ability to comprehend videos just like humans do. Our models have redefined the standards in video-language modeling, empowering us with more intuitive and far-reaching capabilities, and fundamentally transforming the way we interact with...
-
Head Cheer Coach
7 days ago
San Francisco, California, United States California Department of Education Full timeRequirements / QualificationsJob SummaryJob SummaryMercy High School, Burlingame Cheer Position Description Job Title:Head Cheer Coach Department:Student Life Reports To: Athletic Director FLSA Status: Exempt/Hourly Employee Prepared By:Kelly Hickey Preparation Date: February 5, 2024 Summary: Within the context of the tradition and charism of the Sisters of...
-
San Rafael, California, United States BioMarin Pharmaceutical Inc. Full timeWho We Are BioMarin's Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarin's cutting-edge manufacturing processes and sites, provide quality assurance and quality...
-
San Rafael, California, United States BioMarin Pharmaceutical Inc. Full timeWho We Are BioMarin's Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarin's cutting-edge manufacturing processes and sites, provide quality assurance and quality...
-
Product Head of Operating Systems
3 weeks ago
San Francisco, California, United States Block Full timeCompany DescriptionIt all started with an idea at Block in 2013. Initially built to take the pain out of peer-to-peer payments, Cash App has gone from a simple product with a single purpose to a dynamic ecosystem, developing unique financial products, including Afterpay/Clearpay, to provide a better way to send, spend, invest, borrow and save to our 47...
-
Product Head of Operating Systems
1 month ago
San Francisco, California, United States Block Full timeCompany DescriptionIt all started with an idea at Block in 2013. Initially built to take the pain out of peer-to-peer payments, Cash App has gone from a simple product with a single purpose to a dynamic ecosystem, developing unique financial products, including Afterpay/Clearpay, to provide a better way to send, spend, invest, borrow and save to our 47...
