Senior Quality Engineer
Why Join ACIST?
We care as much about our employees as we do our patients. Our culture fosters a work environment where employees can thrive, be passionate and have fun along the way. Each member of the ACIST team has the power to make a difference......every day!
Provide product quality, supplier quality, design assurance, and quality-by-design input and expertise to the development of new medical devices, as well as changes to existing commercialized devices. Provide direction in product risk management throughout entire product lifecycle and assure compliance to ACIST design control procedures, applicable regulations and external standards. Works collaboratively with Product Quality Team to deliver results that improves the overall product platform. Identify areas of improvement, and either lead the necessary activities to completion or participate as an active member providing guidance to the team.
Provide hands-on technical quality engineering support for new product transitions internally and externally into commercialized production including development of quality requirements/plans for new products, design/process validation requirements, test method validation and ongoing change management for finished device manufacturing. The role works upstream and downstream ensuring the total product lifecycle is maintained and that our products continue to perform as designed.
Product Quality Engineering
Leadership and Supervision
Qualifications (Knowledge, Skills & Abilities):
- BS in Engineering or related experience with a comparable science degree.
- 5+ years engineering experience
- 3-5 years of experience in the Quality Engineering/Design Assurance capacity in the medical device industry
- Strong working knowledge of the FDA Quality System Regulation, ISO 13485, and the Medical Device Directive
- Demonstrated knowledge and proficiency in the application of ISO 14971 and other standards related to product design and medical devices
- Experience managing design assurance/quality engineering deliverables for medical device systems (e.g. medical devices that utilize electro-mechanical components, software, and associated consumable devices)
- Demonstrated knowledge and proficiency in quality principles and best practices
- Moderate level of computer proficiency including MS Word, Excel, and statistical applications software
- Effective oral and written communication skills
- Effective technical writing skills
- Strong leadership skills with the ability to influence without direct authority
- Ability to work effectively with suppliers and contract manufacturers
- Ability to lead supplier audits and overall qualifications and maintenance
- Demonstrated knowledge and proficiency in problem solving, root-cause analysis, and corrective and preventative actions
- Demonstrated knowledge and proficiency in statistics, data analysis and trending, and reporting of results.
- ASQ CQE (Certified Quality Engineer) or 6 Sigma discipline
- Demonstrated knowledge of pre-market submission in U.S and Europe
- Skilled in the application of statistical methods, including ANOVA, statistical process control, sampling plans, gauge R&R, and design of experiments
- Skills in other technical areas such as verification testing, sterilization validation, and software quality
- Mental demands – work is detail oriented, often with multiple priorities. The environment is deadline sensitive and may be exposed to high-pressure situations.
- Travel requirements are minimal. Travel to facilities would be about 1-3 days duration each trip with total travel expected to be less than 10%.