Electronics Assembly Jobs

Director, Medical Quality Assurance

Date Posted:

June 21, 2022

Job Category:

Engineering Quality Control

Location:

Strongsville, Ohio, USA

Job Description:

Spartronics develops, manufactures, and manages the full lifecycle of robust electronic and electromechanical devices for commercial aerospace, defense, space, instrumentation and control, life sciences and medical device applications. Our proven experience in complex problem solving, uncompromising attention to detail, program management and thorough documentation processes enables our customers to achieve excellence.


The Medical Segment Director is responsible for assuring the health and operation of the overall quality management systems and the Quality Assurance functional organizations for the medical segment sites.  The Medical Segment Director has leadership responsibility for quality-related aspects of customer requirements, design, supply base, manufacturing, test, service, etc. through the appropriate application of Quality Engineering, Supplier Quality, Quality Assurance, Quality Control, and Continuous Improvement processes for the medical sites.  The Medical Segment Director works with the site Quality Leaders and stakeholders throughout the company to continuously improve processes and capabilities, while assuring cost-effective compliance to internal, customer, and regulatory requirements.  The Medical Segment Director continuously plans, measures, prioritizes, improves, and works to remove constraints to balance customer advocacy with Spartronics business success.


Responsibilities

Promote and assure a safe and respectful team-based working environment
Partner with all stakeholders and functional organizations to assure timely and effective communications, reporting, and customer support
Lead, harmonize, and continuously improve site quality management systems, quality assurance organizations, and continuous improvement programs to provide additional value back to the business
Assure the interpretation of customer, regulatory, and internal requirements into program and product specific quality planning and procedures for use in design, purchasing, inventory, manufacturing, test, inspection, and customer service
Assure the overall certification, evaluation, auditing, compliance, and continuous improvement of the medical Quality Management Systems (QMS) to required industry standards (e.g., 13485, FDA CFR 820)
Identify and drive proactive risk reduction, failure analysis, root cause determination and permanent corrective action and facilitate continuous process improvements
Work with internal and external customers to efficiently analyze, resolve, and manage quality-related issues that arise to prevent negative impacts to product quality, service, schedule performance, and/or cost (e.g., internally caused, supplier-caused, and customer-warranty)
Assure development and deployment of quality engineering processes (e.g., FAIR, Validations, Control Plans, PFMEA, Inspection Plans, Source Inspection documentation, etc.) in support of business needs
Assure data availability, traceability, and product integrity in support of customer requirements
Consolidate, analyze, and report process and product quality results and issues to management and customers
Other duties as assigned by senior leadership

Requirements and Skills

Strong customer service attitude and approach
Ability to develop and maintain strong working relationships with suppliers, external customers, and internal partners
Excellent analytical ability for process and product related data
Ability to utilize a variety of techniques to assess root cause and solve problems
Ability to manage multiple projects and/or issues simultaneously
Ability to lead problem solving investigations and continuous improvement teams
Excellent presentation and communication skills, both written and oral
Strong experience with MS Office tools, (e.g. MS Excel, MS Word, and MS PowerPoint)

Key Metrics and Focus Areas

Effective Quality Management System execution, auditing, and improvement
Proactive Quality Engineering and Supplier Quality processes and customer focus
Effective Continuous Improvement program management and Return on Investment
Effective Root Cause Analysis and Corrective Action program management
Effective and timely Customer Corrective Action Response management
Process data analysis, and effective non-conforming material control and reduction
Scrap / Rework analysis and reductions
Facilitation of Cost of Poor Quality programs and strategic cost reduction opportunities
Return Merchandise Authorization (RMA) program management and customer focus

Requirements
Education/License/Experience Required

Bachelor’s degree in a STEM field (equivalent education or work experience may be a substitute)
Master’s degree in business or engineering (desired)
Six Sigma or equivalent certification (e.g., Black Belt) (preferred)
10 – 20 years of Quality-discipline related work experience with electronic assemblies
5 – 10 years of management experience, including direct management of people
5+ years of related work experience in the medical products sector
FDA 21 CFR 820 compliance
Audit experience with current ISO 9001 and 13485 Quality Management Systems (auditor certification desired)
MDSAP (Medical Single Audit Program) compliance (desired)
MDR (EU), ANVISA, MHLW, HC, TGA compliance (desired)
Root Cause / Corrective Action / Complaint Handling
Process Validation / Risk Analysis
Material Review Board / Nonconforming Material Control
IPC and J-STD electronic assembly certifications (desired)
This position will have oversight of other Medical Quality facilities -Watertown, SD and Milpitas, CA
Ability to travel 25% to other locations.
Spartronics LLC is an Equal Opportunity, Affirmative Action Employer – EOE/MF/V/D. 

Apply for Director, Medical Quality Assurance

Director, Medical Quality Assurance job listing has been viewed 258 times

Inline Cleaning Machine Hydro-clean Array

fluid dispensing pumps for integration