About the Role
The Senior Quality Engineer provides support and leadership to ensure successful development of products and processes, production and process controls, continuous improvements, and corrective actions. The Senior Quality Engineer also leads teams to execute quality related projects, to write and execute validation plans, set-up and verify statistical sampling plans, lead CAPA activity, implement production and process controls, and mentor team members.
Essential Duties & Responsibilities: (Prefer in descending order of significance)
- Apply knowledge of quality engineering techniques to positively influence new product/process development and production efforts, including specification development, verification, corrective action, equipment/process validation, and risk management.
- Act as subject matter expert on Quality Systems and Quality Engineering methodologies.
- Successfully address complex engineering or production issues where analysis of situations or data requires an in-depth evaluation of factors supporting requirements, such as CAPA's, audits, complaints and sustaining activities.
- Provide input to project deliverables, including specifications, drawings, inspection procedures, and manufacturing procedures, to ensure the product can be adequately inspected and tested.
- Assist in the development and maintenance of company procedures.
- Lead or support internal or external audits or assessments.
- Provide coordination of nonconforming materials and customer complaints. Monitor customer complaints, track data, and present the trends to management.
Requirements:
- BS degree in technical discipline
- 5-10 years in related work experience
- Direct experience in quality within a plastic manufacturing environment, demonstrating an understanding of major quality management processes and practices such as GMP Standards, Statistical Process Control, complaint handling, product testing, and internal quality auditing preferred.
- Understanding of regulatory, quality system development, documentation, and implementation with respect to domestic and international standards or requirements (ISO9001, ISO13485, 21CFR 820)
- Technical knowledge of medical verification and validation (IQ, OQ, PQ) preferred.
- ASQ and/or Six Sigma certification preferred.
- Strong interpersonal, communication, influencing and negotiation skills with the ability to work with teams and customers
- Detailed orientated with strong analytical and problem-solving skills
- Excellent organizational skills and the ability to multi-task in a fast-paced environment
- Experience using Mini Tab and programable measurement systems preferred.
Physical Demands:
- The employee is required to use their hands to touch and handle objects, sit, verbally communicate, pass a color differentiation test, and hear.
- The employee is required to walk and stand. The employee must occasionally lift and/or move up to 20 pounds. Specific vision abilities required by the job include close vision and ability to adjust focus.
Closing Statement:
The Senior Quality Engineer is responsible to lead teams to execute quality related projects, validation plans, set-up and verify statistical sampling plans, lead CAPA activity, implement production and process controls, and mentor team members to achieve results. Other job duties and responsibilities may also be assigned by the incumbent's supervisor at any time based upon Company need.
