GROW WITH US:
Tandem Diabetes Care creates new possibilities for people living with diabetes, their loved ones, and their healthcare providers through a positively different experience. We’d love for you to team up with us to “innovate every day,” put “people first,” and take a “no-shortcuts” approach that has propelled us to become a leader in the diabetes technology industry.
A DAY IN THE LIFE:
Responsible for the overall quality and compliance of the area of responsibility developed by the company. Manages the sub-department of R&D Quality Engineering to determine quality systems and requirements and provide design quality and quality engineering support for product development process, including cross-functional cooperation as part of core product development teams and transfer to manufacturing or commercialization.
- Manages R&D Quality Engineering department personnel.
- Serves as a Quality lead on product design/development and sustaining engineering project teams.
- Drive functional excellence in design quality by coaching and mentoring on product design control and development best practices via creating, using, and maintaining the risk management file(s) throughout the product’s full life cycle.
- Provide critical quality engineering direction to projects concerning generally accepted quality engineering tools/principles, such as product and component qualification, process validation, measurement systems analysis, test method validation, root cause analysis, risk analysis, risk mitigation, sampling, and control plans.
- Work cross-functionally to evaluate new projects, assign quality resources to core teams, ensure resourcing aligns with company priorities, monitor progress, identify and resolve technical issues, and manage escalations.
- Assists in the review and approval of product changes/new designs to ensure they are developed, verified, validated, and documented in accordance with Tandem’s Quality Systems and regulatory requirements.
- Provides quality input to Complaint, FI, CAPA, NCR investigations and executes corrective actions when applicable.
- Collects process metrics and lessons learned, reviews and evaluates processes and work products and recommends improvements as appropriate.
- Facilitates or represents quality in lean initiatives through team events, standard lean tools, and documented communications, where the targeted results are a collaborative agreement with management.
- Supports the short and long-term planning for the department including headcount, budgeting, training, and systems requirements.
- Participates in the selection, development, performance appraisal, merit recommendation, and promotion of staff.
- Ensures department staff is properly trained, per designated training plan, before assuming job responsibilities.
- Develops and manages schedules and performance requirements of staff.
- Confirms completion of required training plans before assigning job responsibilities.
- Ensures work is performed in compliance with company policies including Privacy/HIPAA and other regulatory, legal, and safety requirements.
- Performs other assignments or projects as directed.
YOU’RE AWESOME AT:
- Bachelor's degree in Engineering or equivalent combination of education and applicable job experience.
- 8 years of related experience in the field including:
- 5 years of Quality Engineering experience.
- High volume, sterile, disposable medical device design and application of test standards.
- Experience in design control, software development quality, failure investigation, CAPA, inspection, sterilization, and process validation.
- Proven ability to lead teams and obtain targeted results.
- Experience in hardware, software development, and digital platform products.
- Proficient knowledge of quality standards: ISO 9001, ISO 13485, IEC 62304, ISO 11137, 21CFR Part 820 and other appropriate industry standards.
- Strong knowledge and application of principles outlined in Good Manufacturing Processes (GMP).
- Capable of using statistical techniques: sampling theory, probability, reliability, and capability, SPC, GR&R, MSA, DOE, IQ/OQ/PQ and GLP.
- Ability to dive into details, translate and statistically analyze data, and effectively report results through written and/or graphical formats.
- A positive approach to people and problem solutions along with a strong sense of discretion and the ability to maintain confidentiality.
- Familiarity with an object-oriented programming language.
- Strong technical contributor and leader in the quality engineering team.
- Able to recognize non-conformances from accepted and documented practices.
- Skilled at clearly conveying in-depth knowledge to all levels within, and outside of, the organization.
- Excellent verbal and written communication skills and flexibility to function in a fast-paced and innovative environment.
- Able to objectively evaluate situations and make recommendations for changes in light of overall project demands.
- Ability to effectively use MS Office suite (Word, Excel, Outlook) and MiniTab and other applicable software packages.
EXTRA AWESOME:
- Certified Quality Engineer, Six Sigma Blackbelt, Quality Auditor, Reliability Engineer, or equivalent desired.
- Lean manufacturing and Six Sigma experience desirable.
COMPENSATION & BENEFITS:
The starting base pay range for this position is $138K - $172K annually. Base pay will vary based on job-related knowledge, skills, experience and may also fluctuate depending on candidate’s location and the overall job market. In addition to base pay, Tandem offers a competitive compensation package that includes bonus, equity, and a robust benefits package.
Tandem offers health care benefits such as medical, dental, vision, health savings accounts and flexible saving accounts. You’ll also receive 11 paid holidays per year, a minimum of 20 days of paid time off (starting in year 1) and have access to a 401k plan with company match.
YOU SHOULD KNOW:
Qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable state and local Fair Chance laws and regulations. A conditional offer of employment from Tandem is contingent upon successful completion of a thorough screening process comprised of a drug test (excluding Marijuana) and background check, which includes a review of criminal history information.
APPLICATION DEADLINE:
The position will be posted until a final candidate is selected for the requisition or the requisition has a sufficient number of applications.
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