Posted on 09/03/2021
The primary responsibilities include assisting in examination and approval of components and finished products, equipment, processes and related documentation. Utilizing different tools and techniques, the Quality Engineer will help ensure that only the highest quality products are delivered to our customers.
Major Duties & Responsibilities
- Conducts and supports investigations of manufacturing nonconformities; recommends, develops and implements effective corrective actions.
- Coordinates, collects, analyzes and distributes quality monthly and quarterly metrics.
- Uses analytical methods to assess product and process performance and quantify the effect of changes.
- Participates in audits conducted by regulatory agencies and/or customers.
- Conducts internal audits of processes and outcomes.
- Participates in supplier evaluation and selection assessments.
- Participates in risk assessment and risk management activities including FMEA and development of control plans.
- Ensures appropriate compliance and operational effectiveness in all areas of the QMS including document control, change control, training, complaint handling, CAPA, nonconforming process and auditing (internal and external).
- Works in collaboration with Product Development to ensure that the designs, procedures and outcomes of the project are acceptable in quality.
- Proficient with Microsoft Word, Excel & PowerPoint.
- Proficiency with Minitab, JMP or other statistical software suites is a plus.
Minimum Skills & Abilities
- Experience with ISO 13485 and ISO 9001 certification and FDA’s 21CFR 820 preferred.
- Demonstrated experience with mechanical measurements and understanding of GD&T required.
- Experience in a Good Manufacturing Practice (GMP) environment is required.
- Extensive experience writing and implementing policies, processes and procedures is required.
- ASQ certified Quality Auditor and/or Quality Engineer is preferred but not required.
- CQE, CRE, PE, CRA Certifications are highly desirable.
- Lean Six Sigma Green or Black Belt required.
- Experience with statistical methods including measurement system analyses, process capability analyses, regression analyses, tests for equal means and variances and design of experiments.
- LIMS and ISO 17025 experience is a plus.
- Excellent written and oral communication skills.
Minimum Education & Experience
Required Education and Experience
- Minimum of 5 years of overall QA experience in an ISO (FDA is a plus) regulated environment, with at least 3 years in a direct Quality role is required.
- College degree is preferred but not required (5 years with degree/10 years without).