Sr. Product Quality Engineer
4 weeks ago
Pay range $100K- 110K
Essential Functions
- Lead investigations of manufacturing nonconformities and assist manufacturing in implementing effective corrective actions
- Participates in audits conducted by regulatory agencies and/or customers and conducts internal QMS and manufacturing processes audits.
- Apply statistical process control (SPC) methods to evaluate current processes and process changes
- Collaborate and support company-wide CAPA and non-conformance implementation and continuous improvement projects
- Participates in supplier auditing, evaluation and selection process. Works with supplier to address supplier related nonconformities.
- Participates or lead risk management activities including FMEA and development of control plans
- Ensures compliance and operational effectiveness in all areas of the QMS including 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 meeting customer and QMS requirements
- Collaborate with cross-functional teams to establish and maintain quality control processes and procedures
- Monitor and track key quality metrics, creating reports to identify trends and areas for improvement
- Adhere to safety, environmental, and quality-related policies and procedures in the facility.
- Performs other duties as required.
- Must be able to work independently and as a member of a cross-functional team, to multi-task and do what it takes to meet high expectations and tight deadlines.
- Demonstrated proficiency in basic metrology and GD&T.
- Proficiency in applying quality problem-solving methods like FMEA, SPC, control plans, etc.
- Analytical thinking, attention to detail, problem-solving, and failure analysis aptitude
- Possess a strong quality mindset, ability to handle tight deadlines, and manage multiple priorities.
Competencies
Required:
- Bachelor's degree in an engineering discipline with effective communication and interpersonal skills for establishing relationships internally and externally
- Experience with statistical methods including MSA, process capability analyses, and design of experiments.
- Proficient with Microsoft Word, Excel & PowerPoint, Minitab (or other statistical software suites)
- Demonstrated proficiency leading teams and projects using a fact-based problem-solving methodology (DMAIC or 8D).
- Experience with developing, writing and implementing processes and procedures.
- Demonstrated ability to understand and communicate complex technical, statistical and compliance subject matter.
- Ability to manage and prioritize multiple activities with varying business, compliance and customer drivers
Desired:
- ASQ certified Quality Auditor and/or Quality Engineer.
- Lean Six Sigma Green or Black Belt.
- Experience in a Good Manufacturing Practice (GMP) environment.
Supervisory Responsibility
This position has no direct reports.
Required Education and Experience
- Minimum of 8 years of overall Engineering experience in an ISO (regulated environment, with at least 5 years in a direct Quality role is required
- College degree or equivalent is required.
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