Product Quality Engineer II
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, design assurance, and supplier quality input and support to new and commercially available products. This role collaborates with others in the organization to deliver results that improve the overall product performance. Identify areas of improvement and lead the necessary activities to completion, or participate as an active member providing guidance to the team. Provide support to product risk management throughout the entire product lifecycle and assure compliance to ACIST design control procedures, applicable regulations and external standards. The role works upstream and downstream ensuring the total product lifecycle for ACIST products is maintained and that they continue to perform as designed.
Primary Duties and Responsibilities:
Product Quality Engineering
- Provides direction and support to product development teams.
- Lead product risk management activities from planning, analysis, verification, and reporting.
- Provide engineering expertise and support for product testing and verification activities.
- Work with Engineering to develop production acceptance criteria, test methods, and validation protocols.
- Support new product development for respective product line and lead/participate in gate reviews and follow up activities ensuring all documentation and data supports the approval process.
- Lead risk analysis and risk management for assigned product through all phases of the product life cycle and author the annual post market surveillance and drive resolution of identified risks.
- Provide engineering support for external testing qualification such as UL / IEC testing, and appropriate statistical methods, including sample size determination
Qualifications (Knowledge, Skills & Abilities):
- BS degree in Engineering or comparable science discipline.
- 3-5 years engineering experience
- 2+ years of experience in the Quality Engineering, Supplier Quality, and/or Design Assurance capacity in the medical device industry
- Working knowledge of process validation, test method validation, and R&R study
- Demonstrated knowledge and effective application of quality tools (e.g., Six Sigma, DOE, process analysis/capability, FMEA, root cause analysis, statistical data analysis, CAPA)
- Working knowledge of the FDA Quality System Regulation and ISO 13485
- Experience supporting design assurance/quality engineering deliverables for medical device systems
- Ability to influence without direct authority
- Ability to establish effective relationships with suppliers
- Moderate level of computer proficiency including MS Word, Excel, ERP systems, and statistical applications software
- Strong written and verbal communication skills to effectively translate ideas, concepts and information
- Ability to develop clear, concise, and timely oral and written reports
- ASQ CQE (Certified Quality Engineer) or 6 Sigma discipline
- 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 moderate. Travel to facilities would be about 2 – 3 days duration each trip with total travel expected to be approximately 10-15%.