- $90,000-150,000k annually
- relocation bonus available
- Join a growing team of health care, supply chain, manufacturing, and global sourcing professionals that are improving patient care and making communities healthier
- Ensure ongoing compliance to FDA requirements while improving and optimizing the quality system and transitioning to ISO 13485
- Ensure facility is able to deliver high quality products to customers by working with Operations to reduce in-process defects, customer complaints and recalls
- Work to develop strong culture of Quality across all departments within the facility that will facilitate and support growth
- Quality Management System oversight
- Quality Reporting and Process Improvement
- Supplier Qualification, Internal Audits and CAPA Management
- Establish and maintain a Quality Management System at ROi CPS, LLC that is compliant with 21 CFR Part 820. Review and approve quality system documents, reports and records.
- Ensure Quality Records are established and available, as required by 21 CFR Part 820 and the ROi CPS Quality System. Ensure electronic records and signatures comply with 21 CFR Part 11.
- Ensure adequate Process Controls and Quality Controls are defined and implemented throughout the production process to ensure customer and regulatory requirements are met.
- Collect, analyze and trend quality data. Provide quality performance data for reports and provide evidence-based recommendations for process improvements.
- Supervise Quality Assurance Technicians and Quality Control Technicians.
- Must be able to collaborate with various departments, friendly and professional but able to hold their ground when dealing with Operations and making decisions that may negatively impact Operations or Financials
- BA/BS in sciences, engineering preferred
- Minimum 5 years of proven experience in the medical device industry
- Minimum 2 years of experience in a supervisory or management role
-
Validation Engineering Manager, ADC Manufacturing
Found in: Talent US 2A C2 - 23 hours ago
Laguna Source California, United StatesValidation Engineering Manager, ADC Manufacturing - Songdo, South Korea · This is a stellar opportunity responsible for leading ADC Validation Engineering processes and serving as a SME for ADC manufacturing. This is a once-in-a-lifetime Global Expat leadership opportunity within ...
-
Medical Device Manufacturing QA Manager
Found in: ZipRecruiter Test10S US C2 - 2 days ago
Jenn Nguyen and Friends Republic, United StatesJob Description · Job DescriptionWho are we? We are healthcare professionals with expertise in Supply Chain, Manufacturing & Global Sourcing. We supply the nation's leading healthcare systems with medical supplies and custom procedure trays under our "Regard' brand. We also offer ...
-
PCB Materials Manufacturing Sales Account Manager
Found in: Appcast US C2 - 23 hours ago
Top Talent Search Experts, LLC California, United StatesOur client is a worldwide leader in the development of High-Performance Substrates and related Materials for the Electronics PCB Industry. We are seeking a Driven and Competent Sales Account Manager to help expand and continue the company's ongoing growth and transformation. · Lo ...
-
Senior Manufacturing Engineer, Instruments
Found in: Appcast US C2 - 23 hours ago
Cytovale California, United StatesThis key role partners with our Contract Manufacturers (CMs) to ensure Supply, Quality, and Cost targets are achieved for successful clinical operations, and commercialization. · As the Senior Manufacturing Engineer, you will be a key member of the Operations team. You will repre ...
-
lab support specialist
Found in: MyJobHelper US C2 - 2 days ago
CYNET SYSTEMS , CA, United StatesJob Description: · Pay Range: $55hr - $60hr Workstation support, including direct support to end-users ranging from Tier 1 - 2 type issues Understanding of the business processes and all applicable procedures, including in-depth knowledge of GxP operations as it relates to t ...
-
director biologics api chemical development cmc
Found in: MyJobHelper US C2 - 2 days ago
Clinical Dynamix, Inc. , CA, United StatesAbout the Role: · Seeking a highly motivated and talented biologics leader within CMC (antibodies, gene therapy) in the areas of upstream and downstream API development, optimization and manufacture. The successful candidate will work on research and development of biologics proc ...
-
Plant Manager
Found in: Appcast US C2 - 3 days ago
DSJ Global California, United StatesA Leading Food/Beverage Manufacturer is in need of a plant Manager to join their growing team · Job Title: Plant Manager · Manufacturing Plant · Dessert/Chocolate Manufacturing Plant · Location: Greater Los Angeles, CA · A multi-million dollar food/beverage firm is seeking to ...
-
environmental health
Found in: MyJobHelper US C2 - 2 days ago
RSS, LLC. , CA, United StatesJob Details · Level · Management · Job Location · Construction Innovations - Plant - Sacramento, CA · Position Type · Full Time · Salary Range · $72, $112,400.00 · Travel Percentage · Negligible · Job Shift · Day · Description · OVERVIEW: · The Environmental Health & Safety Mana ...
-
Director of Manufacturing Engineering
Found in: Appcast US C2 - 3 days ago
Hyve Solutions California, United StatesDirector, Manufacturing Engineering · Hyve Solutions is a leader in the data center solutions industry. We design, manufacture, and deliver custom Server, Storage, and Networking Solutions to the world's largest Cloud, Social Media, and Enterprise companies. We pride ourselves on ...
-
executive director, cell therapy cmc
Found in: MyJobHelper US C2 - 2 days ago
BeiGene , CA, United StatesWe are seeking an exceptional and highly motivated CMC leader to join the BeiGene Cell Therapy team to enable the cell therapy development. Ideal candidate must be proficient in both CMC strategic planning, execution, and matrix team management. The successful applicant will spea ...
-
quality auditor
Found in: MyJobHelper US C2 - 2 days ago
SQA Services , CA, United StatesSQA is a leading Quality Assurance and Supply Chain solutions firm. SQA manages Supplier Audit and Supplier Development programs for clients in quality-critical industries, including Pharmaceutical, Medical Device, Automotive, Aerospace, and Electronics manufacturing. Clients lev ...
-
Plant Manager
Found in: Appcast US C2 - 2 days ago
DSJ Global California, United StatesTitle: Plant Manager · Location: Greater Los Angeles, CA Area · A leader within chemical manufacturing is seeking out a Plant Manager to join their team and be a critical part of the strategic business decisions. · The Plant Manager will be accountable for providing leadership an ...
-
Director of Operations
Found in: Appcast US C2 - 2 days ago
Accordance Search Group California, United StatesQualifications: · 10 years of experience; must have direct experience in manufacturing, supply chain, and engineering · 4 years of management experience in supply chain, manufacturing or engineering · Experience on product development teams · Experience scaling up manufacturing/s ...
-
Senior Application Engineer
Found in: Appcast US C2 - 23 hours ago
BizLink Tailor-Made Products California, United StatesBizLink elocab Ltd, is a leading manufacturer of custom cables and custom cable systems. We are a high growth company selling to Fortune 500 firms with branches around the globe. We are considered to be a technology leader in providing custom designs and production for demanding ...
-
Account Development Representative
Found in: CV Wallet US A2 - 1 week ago
Arrow Electronics California, United States OTHERPosition: · Account Development Representative · Job Description: · Arrow is a Fortune 109 company headquartered in Denver, CO, with employees worldwide. Arrow brings technology solutions to various markets, including telecommunications, information systems, transportation, medic ...
-
call center operations manager
Found in: MyJobHelper US C2 - 2 days ago
A Team Staffing , CA, United StatesA Team Staffing, Southern California's locally-based staffing firm specializing in the title, escrow, mortgage and real estate industries, has an immediate opportunity for a Call Center Operations Manager to lead the customer service team for a leadi Operations Manager, Operation ...
-
night warehouse manager
Found in: MyJobHelper US C2 - 1 day ago
US Foods Holding Corp , CA, United StatesARE YOU A CURRENT US FOODS EMPLOYEE? PLEASE APPLY DIRECTLY THROUGH OUR INTERNAL WORKDAY CAREER SITE. Join Our Community of Food People Schedule-Sunday-Thursday start 6 PM - The Manager, Warehouse will ensure a warehouse culture focused on people, sa Warehouse Manager, Manager, Wa ...
-
sr. cannabis lab technician
Found in: MyJobHelper US C2 - 2 days ago
Claybourne , CA, United StatesWe are Claybourne, one of the fastest growing cannabis flower brands in California. Our team is known for being highly dedicated to our retail partners and consumers while going above and beyond with flower quality, flower consistency and innovative new product development. We ar ...
-
Quality Laboratory Manager
Found in: Appcast US C2 - 19 hours ago
Kelly Science, Engineering, Technology & Telecom California, United StatesKelly Science & Clinical is seeking a Quality Laboratory Manager for a direct hire opportunity with one of our clients, a leading nutraceutical manufacturer in Valencia, CA. If you're passionate about bringing the latest scientific discoveries to life and are ready to take the ne ...
-
assistant branch utility officer
Found in: MyJobHelper US C2 - 2 days ago
Manufacturers Bank , CA, United StatesAssist the Utility Officer with the semi-annual operational audits of the branches and provide coverage for branches in the absences of the Branch Service Manager, Assistant Branch Service Manager, Branch Service Supervisor or other areas as needed. Officer, Utility, Assistant, O ...
Medical Device Manufacturing QA Manager - Republic, United States - Jenn Nguyen and Friends
Found in: Manatal GBL S2 T2 - 38 minutes ago
Description
Who are we? We are healthcare professionals with expertise in Supply Chain, Manufacturing & Global Sourcing. We supply the nation's leading healthcare systems with medical supplies and custom procedure trays under our "Regard' brand. We also offer end-to-end supply chain solutions including logistics management and 3PL storage services.
What's in it for you?
What will you do? The ROI CPS, LLC Quality Assurance Manager is responsible for developing and implementing policies and procedures that support custom procedure tray manufacturing Quality System in accordance with 21 CFR Part 820 and other applicable regulations and guidance. This role is key to ensuring customer and regulatory requirements are met by establishing a strong culture of quality.
What will you need?