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!
The Product Quality Engineer II provides product quality, design assurance, and supplier quality input and support for products manufactured by ACIST Medical Systems. This role collaborates with the Product Quality Team to deliver results that improves products and identifies areas of improvement. This role also provides direction in product risk management throughout the entire 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 is maintained and that our products continue to perform as designed.
Primary Duties and Responsibilities
Global Product Quality Engineering
- Provide quality oversight and support to internal and external manufacturing.
- Lead the investigation, analysis, and report on product complaints and coordinate cross-functional actions as needed.
- Provide leadership and QA support for NCMR and CAPA activities relating to products and processes.
- Review and approve change orders related to product/process changes, including approval of procedures and work instructions for manufacturing and inspection.
- Provide leadership and QA support for validation of production and test processes.
- Establish robust manufacturing process metrics and monitor results regularly to proactively identify potential problems and drive continuous improvement.
- Provide guidance and support for product development teams.
- Provide engineering expertise and support for product testing and verification activities.
- Work with Engineering to develop production acceptance criteria, test methods, and process 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, technical standards interpretation, and appropriate statistical methods, including sample size determination.
- Generate the QA deliverables to meet the project scope and plan.
- Participate in and lead supplier evaluation, qualification and approval activities including audits.
- Provide quality support for incoming inspection plans, procedures, and sampling methods to ensure product quality.
- Assist in defining critical attributes and characteristics to be measured for components and products.
- Define component qualification plans and approve first part review results.
- Own and complete Supplier Corrective Action Requests (SCAR), interfacing directly with suppliers.
- Oversee supplier validations, change orders, and any changes to form, fit, or function of the device.
- Provide direction and oversight to contract manufacturer for quality concerns, product inquiries, validations, safety, etc.
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, ISO 13485, and the Medical Device Directive
- 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
- ASQ CQE (Certified Quality Engineer) or 6 Sigma discipline
- Ability to coordinate multiple projects simultaneously
- 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 3-5 days duration each trip with total travel expected to be approximately 10%.