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The Senior Quality Engineer is responsible for providing quality engineering support for manufacturing POGO meter and cartridges on a day-to-day basis to ensure regulatory compliance.
Duties and Responsibilities:
- Work with Product Development, Operations and other departments to ensure regulatory compliance to POGO meter and cartridge manufacturing in accordance with 21CFR820 and ISO 13485.
- Develop and execute Quality Engineering activities to meet commercial milestones
- Support the analysis and evaluation of production capabilities, manufacturing problems, and the design and development of new products from the quality assurance perspective.
- Develop and implement product quality plans, documents and systems by creating product specifications, quality specifications, quality plans, risk analyses, and FMEAs to provide a high degree of assurance that specific design and processes will consistently and continually produce a product that meets specifications and critical-to-quality attributes
- Perform DHR Review of manufacturing performed while working on potential improvements to the overall documentation process.
- Participate in Risk Management efforts in accordance with ISO 14971 and Design Control efforts in line with ISO 13485, 21CFR 820 and IVDD.
- Train and mentor team members on best practices in quality engineering and regulatory compliance.
- Train, support, and encourage team members in the use of quality tools such as root cause analysis, risk analysis, FMEA, DOE, and statistical methods.
- Review and draft process validation plans and protocols, and conduct validation testing of new or updated products and equipment, fixtures or tools as necessary.
- Assist in the development, improvement, and management of product assurance systems such as incoming quality inspection, in-process quality assurance, statistical process control, calibration / preventative maintenance, CAPA, nonconforming materials, product lot release testing, and finished goods control.
- Participate in internal and external audits for quality systems, processes, and products to ensure compliance with regulations and internal specifications.
- 7+ years of experience in a quality engineering role in the medical device industry with experience in complex systems strongly preferred.
- Strong reading, writing and speaking competency in English
- Fluent in a wide variety of Quality tools such as Fishbone, 8D, 6S, 5 Why Analysis processes.
- Word processing, spreadsheet, Internet, e-mail, manufacturing, statistical and database software such as Minitab or JMP.
- Working knowledge of regulatory requirements such as QSR, ISO13485, and IVDD
- Strong collaboration, team building and development skills
- Strong written, verbal and interpersonal skills
- Prior experience working in emerging, start-up companies desired
- B.S. or higher in Biomedical, Electrical, Mechanical or Systems Engineering or equivalent relevant work experience.
- ASQ CQE (Certified Quality Engineer), CQA (Certified Quality Auditor) or other relevant certification is highly desirable.
Summary of Primary Responsibilities:
The Corporate Controller (CC) is a key leadership position within the Accounting and Finance department reporting directly to the Vice President of Finance. The CC is a hands-on manager and leader in the day-to-day activities of the accounting department, including month-end close process, review of journal entries, internal control compliance, payroll and other special projects. The CC is the lead point person with the external auditors and provides technical recommendations to the accounting team and management. The scope and responsibility of the position is broad and requires extensive in-depth knowledge, skills, and experience. The CC must lead and motivate the team to meet competing and demanding timelines, while also operating at the highest levels with executive leadership. The position has direct and indirect oversite of department staff.
Position Description and Responsibilities:
- Lead and manage the day-to-day accounting operations.
- Provide direct and indirect supervisory and leadership oversight of department staff.
- Streamline and manage month-end financial statement close process, including review of journal entries and account reconciliations.
- Lead and manage quarterly reviews and year-end audit, act as point person with external auditing firms.
- Participate in the implementation of ASC 606
- Oversee all tax work; act as point person with external tax professionals
- Develop, implement, maintain, and update internal controls in accordance with Sarbanes Oxley and COSO framework.
- Provide general oversight for bi-weekly ADP payroll processing and compliance.
- Oversee equity management and risk management functions
- Perform and implement technical accounting research and draft accounting memorandums, as necessary.
- Collaborate with legal on the review of contracts/agreements to ensure financial terms are reasonable.
- Participate in implementation of Third-Party Logistics Provider (3PL)
- Participate or lead special projects and support various accounting related duties as needed.
- Guides financial decisions by establishing, monitoring, and enforcing policies and procedures.
Experience and Requirements:
- Minimum 12 years of finance and accounting experience (minimum five years of public accounting experience required) with at least 7 years of management experience.
- CPA certification and Biotech industry experience is preferred.
- Advanced knowledge of GAAP and of recent accounting trends.
- Solid knowledge of Excel Spreadsheet and MS Word.
- Acute attention to detail and accuracy of work performed.
- Excellent communication, interpersonal, and leadership skills.
- Ability to act and operate independently with minimal daily direction to accomplish objectives.
- Ability to work cooperatively and collaboratively with all levels of employees, management, and external agencies to maximize performance, creativity, problem solving and results.
- A Bachelor’s degree in accounting or business with an emphasis in accounting. An advanced degree is strongly preferred.
- 5 years+ experience in managing a customer support operation (HUB)
- Experience in pharmaceutical, biotech or medical device industries a plus
Intuity Medical, Inc. values diversity and is an Equal Opportunity Employer. No applicant will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law.