Careers

Jobs

Company

The Sr. Accounting Manager is responsible for all areas relating to general ledger accounting functions, financial & tax reporting. This is a highly visible role with exposure to all functional departments and reports to the Controller. In addition to daily and monthly responsibilities, the Manager of Accounting will assist Controller and CFO on the execution and creation of new processes to support our growing organization. The ideal candidate is detail-oriented, self-motivated, team player with a very strong working knowledge of system processes, internal controls, GAAP, IFRS and SOX regulations. The candidate should be comfortable working collaboratively in teams and independently, can handle multiple projects at once, and excels when faced with new challenges and problems to solve.

Job Responsibilities:

  • Assist on the preparation and implementation of corporate accounting policies and related processes
  • Establish, implement and monitor internal controls over operations and accounting functions
  • Maintain the general ledger and all financial records in accordance with US GAAP
  • Responsible of proper reconciliation of G/L accounts
  • Prepare monthly accruals of activities performed, in coordination with department managers
  • Coordinate day to day accounting activities
  • Manage the weekly cash forecasting process
  • Work with Controller on the monthly close activities including cost accounting entries and inventory reporting
  • Prepare monthly financial statements: Balance Sheet, Income Statement, Cash Flows
  • Work with Controller and Manufacturing Managers on setting an annual standard cost process for each product required
  • Global Warehouse and Distribution activities by third parties – accounting transactions, recording and reconciliations
  • Sales tax administration
  • Assist on the annual tax return preparation and submission
  • Facilitate external audit reporting
  • Effectively manage, lead and develop the accounting team hoc projects and analysis

Job Requirements/Qualifications:

  • Must be a CPA/CMA or a CPA/CMA candidate with minimum 5 years of experience; some public accounting experience preferred
  • BS degree in Accounting or other technical field
  • Experience in a dynamic and growing business environment
  • Automation and continued software upgrade experience a plus
  • Strong quantitative, analytical and interpersonal skills
  • Strong attention to details
  • Ability to work independently and as a team
  • Excellent computer proficiency with MS-Office Suite, including advanced knowledge in Excel, as well as financial software. Working knowledge of ERP system, and previous experience with QuickBooks, NetSuite or other accounting systems, a plus
  • Ability to effectively interact cross functionally and with all organizational / management levels
  • Strong communication skills, both verbal and written
  • Strong organization skills, with the ability to manage multiple priorities within a fast-paced environment, while timely meeting deadlines
  • Project management experience in both a lead and support role, with the ability to demonstrate an active contribution to end product
  • Previous experience within a manufacturing environment is a plus

Job Type: Full-time

Company

Looking for a highly motivated and experienced Validation Engineer to partner with our Manufacturing Team’s initiatives, and maintain QMS compliance with the applicable Standards and Regulations. As a Quality Engineer, you will actively contribute to a variety of projects, which include performing process validations, NPI, nonconformance handling and other quality issues with a focus on Process Equipment, GMP, Facilities, and Utilities.

This individual will drive exceptional product quality, safety, design, and reliability through the Manufacturing and Quality teams into the product. The individual will actively participate in risk management, design concepts, design specifications, design for quality and manufacturing requirements, process/technology development, product verification/validation, project management, and associated documentation.

This individual must plan, write, and execute engineering validation protocols, reports, and other technical documents, as well as conduct validation related investigations for our laboratories and manufacturing processes.

This position requires knowledge of process validation principals, manufacturing controls, and application of medical device standards such as ISO 13485 and FDA 21 CFR 820.

Essential Duties and Responsibilities:

  • Work with Product Development, Manufacturing, Quality & Purchasing teams to develop and execute Quality Engineering activities to meet commercial milestones
  • Be an active contributing member of project teams executing various validation projects
  • Develop and execute Installation, Operational and Performance Qualification (IQ/OQ/PQ) Protocols for various manufacturing and measurement equipment
  • Execution of software test protocols, where needed, including identification and resolution of non-conformances/deviations.
  • Participate in nonconformance identification, investigation, and mitigation
  • Perform functional and process risk assessments in conjunction with Quality and Engineering subject matter experts
  • Provide routine progress and issue updates to project teams
  • Perform and document statistical analysis related to validations
  • Coordinate with end users and process owners to help define validation strategies for complex manufacturing systems and processes, and drive improvement activities where needed
  • Ensure qualified equipment are in compliance with Quality System Requirements
  • Assist in the development, improvement, and management of product assurance systems such as receiving quality assurance, in-process quality assurance, statistical process control, calibration / preventative maintenance, nonconforming materials, product lot release testing, and finished goods control.
  • Learn and understand the applicable technologies and engage in technical discussions
  • Identify areas and opportunities to improve manufacturing facilities, processes, and equipment
  • Operate manufacturing and measurement equipment, and perform process characterization/R&D studies in conjunctions with Manufacturing and R&D
  • Other duties as assigned

Required Education and Experience:

  • Work with Product Development, Manufacturing, Quality & Purchasing teams to develop and execute Quality Engineering activities to meet commercial milestones
  • Be an active contributing member of project teams executing various validation projects
  • Develop and execute Installation, Operational and Performance Qualification (IQ/OQ/PQ) Protocols for various manufacturing and measurement equipment
  • Execution of software test protocols, where needed, including identification and resolution of non-conformances/deviations.
  • Participate in nonconformance identification, investigation, and mitigation
  • Perform functional and process risk assessments in conjunction with Quality and Engineering subject matter experts
  • Provide routine progress and issue updates to project teams
  • Perform and document statistical analysis related to validations
  • Coordinate with end users and process owners to help define validation strategies for complex manufacturing systems and processes, and drive improvement activities where needed
  • Ensure qualified equipment are in compliance with Quality System Requirements
  • Assist in the development, improvement, and management of product assurance systems such as receiving quality assurance, in-process quality assurance, statistical process control, calibration / preventative maintenance, nonconforming materials, product lot release testing, and finished goods control.
  • Learn and understand the applicable technologies and engage in technical discussions
  • Identify areas and opportunities to improve manufacturing facilities, processes, and equipment
  • Operate manufacturing and measurement equipment, and perform process characterization/R&D studies in conjunctions with Manufacturing and R&D
  • Other duties as assigned

Required Education and Experience:

  • Bachelor’s Degree in Mechanical/Material Science/Manufacturing Engineering
  • 5+ years of Quality Engineering experience in a medical device regulation environment
  • Good working knowledge of process validation, FMEA, and other risk management activities
  • Experience with ISO 13485, ISO 14971, 21 CFR 820, and MDSAP requirements
  • Fluent in a wide variety of Quality tools such as Ishikawa Diagrams, Fault Tree Analysis, 8D, 5-Why Analysis
  • Ability to deliver results under minimum supervision to accomplish goals while working across departments is required
  • Demonstrated strong analytical problem solving, team collaboration, and communications/interpersonal skills
  • Excellent interpersonal, written, and verbal communication skills
  • Ability to function efficiently in a fast-paced, dynamic work environment with ability to methodically manage multiples tasks assigned
  • Ability to think critically and demonstrate troubleshooting and problem-solving skills
  • Strong background utilizing G-Suite (Google Docs, Google Spreadsheets, Google Slides etc.).
  • Experience with Statistical software (Minitab, JMP)

Preferred Qualifications

  • Working knowledge of Laser Powder Bed Fusion Systems and mechanical testing systems
  • Experience with powder metallurgy is a plus

Physical Requirements:

  • Remaining in a stationary position, often standing, or sitting for prolonged period of time
  • Sedentary work that primarily involves sitting/standing for prolonged periods of time
  • Adjusting, moving, or lifting objects up to 50 pounds
  • Repeating motions that may include the wrists, hands and/or fingers

Job Type: Full-time