Bachelor's degree in Engineering or Science, or equivalent work experience.
Minimum of three years of quality experience in a regulated manufacturing environment.
Working knowledge of ISO 9001, ISO 13485, or similar standards.
Direct experience with metrology equipment and validation activities.
Familiarity with Minitab or other statistical programs.
Proficient in Microsoft Office Suite and Adobe Acrobat Pro.
Excellent analytical, technical, and interpersonal skills.
Responsibilities
Advocate for compliance and documentation of processes.
Review and evaluate product specifications for critical-to-quality attributes.
Engage hands-on with products and measurement equipment.
Drive change control processes and activities.
Participate in CAPA activities as required.
Initiate CCOs and revise or create necessary documentation.
Collaborate with cross-functional teams to identify and address process variability.
Benefits
Opportunity to work on continuous improvement initiatives.
Hands-on experience with product inspection and measurement.
Collaboration with diverse teams including R&D and Supply Chain.
Engagement in CAPA and validation activities.
Exposure to regulated manufacturing environments.
Full Job Description
Summary: The Technical Quality Engineer uses quality and process engineering principles, tools and practices to investigate, analyze, develop and optimize processes for ensuring continued compliance and product quality. The Technical Quality Engineer focuses on technical product or manufacturing process issues and actively participates in continuous improvement initiatives as assigned and offers and supports ideas for improvement.
Essential Duties & Responsibilities:
Sustaining Engineering & New Product Initiation:
Acts as an advocate to ensure processes are compliant and documented.
Reviews, evaluates product specifications and applies appropriate measurement methods to critical-to-quality (CTQ) attributes.
Is hands-on with products, inspection and measurement equipment.
Drive change control processes and activities.
Participates in CAPA activities as required.
Initiates CCOs and revises or creates documentation when needed.
Authors protocols and reports, develops and takes action related to validation activities such as, but not limited to Risk Management, MSA, FAI, IQ, OQ, PQ, PPAP, Gage R&R, Process Capability (statistical process control), DOE, or other studies necessary to initiate or sustain products.
Participate and collaborate with Supply chain, R&D Engineering, Operations Engineering and Manufacturing to identify potential areas of process variability, address root causes and implement improvements.
Evaluates process critical quality parameters and updates specifications and protocols.
Assists in other quality or engineering activities as requested.
Customer Feedback and Nonconformance Support:Required Qualifications:
Documents and Investigates customer feedback and/or nonconformances.
Participate and collaborate with Supply chain, R&D Engineering and Manufacturing Engineering to identify potential areas of process variability, address root causes and implement improvements.
Tracks and reports performance metrics pertaining to Customer Feedback and nonconformances to identify trends.
Corresponds professionally with internal and external customers regarding potential product issues.Required Qualifications:
Required Qualifications:
Bachelor's degree in Engineering or Science, or equivalent work experience.
A minimum of three (3) years related to quality experience in a regulated manufacturing environment.
Working knowledge of ISO 9001, ISO 13485 or other regulated manufacturing industries.
Direct experience with metrology equipment.
Direct experience authoring and participating in validation activities.
Previous familiarity with Minitab or other Statistical Programs.
Highly proficient in the use of Microsoft Office including Outlook, Word, Excel, Power Point, Project, Visio, SharePoint, Teams, and Adobe Acrobat Pro.
Excellent analytical, technical and interpersonal skills.
Demonstrated meticulous attention to detail and accuracy.
Experience working both individually and as part of a team to meet both internal and external customer requirements
Able to perform several tasks concurrently with good time management skills.
Preferred Qualifications:
Experience working with plastics.
ASQ CQE/CQA
Lean Six Sigma (Green Belt or Black Belt)
Prior experience within electronic Quality Management Systems (eQMS) such as CEBOS, Green Light Guru, Master Control, Qualio, Veeva, or similar applications and systems.
Physical Requirements: (with or without the aid of mechanical) The physical requirements described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
