Product Quality Engineer I
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 I provides quality engineering technical support for to the development of new medical devices and changes to existing commercialized devices. This will include development of quality requirements/plans for new products, design/process validation requirements, test method validation and ongoing change management for finished device manufacturing. The Product Quality Engineer plays an active role in the processes to ensure product changes meet quality standards consistent with ACIST Medical Systems policies, while meeting all applicable regulatory requirements. 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 support for manufacturing, inspection & test activities for products
- Support product complaints investigation, analysis and final report creation
- Conducts statistical analysis of product use data (complaints) and nonconformance data for the identification of trends and suggests/coordinates the implementation of necessary corrective actions.
- Provide Quality Assurance support for CAPA and non-conforming material activities relating to products and process, and leading other efforts relating to quality characteristics and conformance to product requirements.
- Review and approve change orders related to product/process changes, including approval of procedures and work instructions for manufacturing and inspection.
- Provide direction and oversight to contract manufacturer for quality concerns, product inquiries, validations, safety, etc.
- Interact with sustaining, regulatory, and operations engineering.
- Provide guidance and support for design verification activities. Assess and approve protocols and reports for test robustness, traceability to requirements, statistical sample sizes, and quality of the test specification.
- Support all risk management activities from planning, analysis and verification, and risk reporting and acceptance.
- Provide engineering support for testing qualifications such as UL / IEC testing, test method development, technical standards interpretation, and appropriate statistical methods, including sample size determination.
- Generate the QA deliverables to meet the project scope and plan.
- Participate in 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.
Qualifications (Knowledge, Skills & Abilities):
- BS degree in Engineering or comparable science discipline
- 2+ years’ work experience, including college intern, in a regulated, structured environment such as medical device systems, aerospace, or automotive
- Some work experience with product test, design assurance, manufacturing engineering, quality engineering, or product development
- Working knowledge and experience with quality systems regulations and guidelines
- Effective writing and communication skills
- Experience creating test plans and reports
- Working knowledge of the FDA Quality System Regulation, ISO 13485, and the Medical Device Regulation
- Interpersonal and communication skills to effectively translate ideas, concepts and information into actions relating to the primary duties
- Ability to coordinate multiple projects simultaneously
- Strong troubleshooting skills and problem-solving mindset
- Medical device and manufacturing industry experience
- Applied experience with statistical techniques such as reliability, gauge R&R, DOE, ANOVA, sampling plans, and SPC
- 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 expected to be less than 10%, international and domestic.