Quality Assurance and Regulatory Affairs Manager, Cornelius, Oregon
Sheldon Manufacturing is a well-established and fast-paced manufacturing company with a culture committed to quality and exceeding customer expectations. Over the past 50 years we have worked with industry leaders to design solutions for production and research needs across the entire constant temperature/environment spectrum, including Vacuum and Forced Air Ovens, Incubators, Shaker Ovens, and multiple State-of-the-Art custom products for high-profile customers. The Quality Assurance and Regulatory Affairs Manager will lead the Quality Department to support manufacturing, engineering, sales, procurement, customer service, and acts as an interface to outside agencies related to maintaining our ISO 9001 certification and out Class I medical products.
Assure Sheldon’s products are compliant to released specifications and national/international directives, such as ISO 9001-Management Representative & Lead Auditor, Hazardous Materials Directives.
Regulatory oversight, to include New Product Development and TUV/UL/CSA Safety Certifications.
Material Review Board Chair, Corrective Action Program, Document Control Manager, Change Order review.
Manage Final Quality Acceptance (FQA) including Inspection and Test
Manage the company’s Calibration Program and the Product Test (Labview-based) System.
Set and report on Key Performance Indicators for the Quality Management Process
Foster and implement Corporate Strategic Initiatives Goals & Measures
Acts as the Quality Engineer for NPI, Manufacturing-Sustaining, and Field Complaint issues.
Maintains product and part nonconformance log.
Interprets the User Manual, BOMs, schematic drawings, and assembly instructions to further root cause determinations provided by failure analysis personnel; Coordinates corrective action decisions.
Provides technical quality leadership and assistance for manufacturing and quality departments.
Develops, evaluates, revises, and applies technical quality assurance protocols/methods to inspect and test in-process raw materials, components, and finished products.
Performs data analysis and generates performance summaries and/or reports from the test data.
Supports materials, production, and engineering groups in resolving supplier quality problems.
Issues periodic reports to management regarding site quality matters.
ESSENTIAL SKILLS and QUALIFICATIONS
Relevant work experience in a manufacturing environment critical.
Requires a technical degree and a working knowledge of metal fabrication and assembly of electro-mechanical products; knowledge of pressure and temperature impacts on performance is a plus.
Familiar with industry standards and project documentation requirements.
Knowledgeable in standard inspection techniques and basic electronics theory / component performance.
Excellent problem-solving skills; ability to determine and to focus on the problem to be solved
Excellent communication skills: -- ability to communicate what you have done and how it supports the problem resolution or hypothesis -- ability to present new ideas in a clear and supportive way -- ability to write effectively for customer consumption
Team player; Personable - ability to work effectively across departments
Possesses a high degree of creative ability, engineering skill and independent judgment. Manages time between multiple assignments while working under critical time deadlines.
Ability to use Microsoft Excel for data analysis and presentation of findings
Possesses Critical Thinking Skills: "does the data look right?" and if not “why?"
Telecommuting is allowed.
Additional Salary Information: Healthcare, STD, and LTD covered, 401k with a match up to 4%, vacation per Employee Handbook
Internal Number: QE01
Sheldon Manufacturing, Inc. is an ISO 9001:2015 certified manufacturer of high quality and innovative constant temperature equipment to the global market. Major product lines include incubators, humidity test chambers, ovens, water and bead baths, and anaerobic chambers for the life science, pharmaceutical, biomedical, environmental and industrial markets. Sheldon Manufacturing markets a complete line of products under the SHEL LAB, BACTRON, Lab Armor, Cascade TEK, and HighPoint which complement our OEM manufacturing capabilities.
Sheldon Manufacturing, Inc. was founded with the goal of being a world-leading manufacturer of constant temperature equipment. For over 50 years Sheldon Manufacturing has worked with industry leaders to design solutions for production and research needs across the entire constant temperature and environment spectrum. This experience is apparent in every project we engineer. Over the years, our reputation has grown as an innovator of dependable and reliable equipment, designed demanding environments.