Quality Specialist

TOGETHER, WE SAVE LIVES

As Product Quality Specialist and as a member of the Product Quality Specialist team, will provide QA support to Med-Eng’s Sensor Program(s) creating quality plans, monitoring Contract Manufacturer(s) performance, assisting with planned inspection, customer acceptance and product audit activities. Provide QA support on other projects, in production and at Med-Eng suppliers to ensure timely supply of quality finished goods. Works with Product Development, NPI, Manufacturing Engineering, Manufacturing Quality and Supply Chain to establish control plans based on design and manufacturing requirements, monitor performance and initiate corrective action when required in accordance with Med-Eng processes and/or customer requirements.

This position interacts with Med-Eng Suppliers, Customers, Quality Organization, Engineering, Procurement, Product Line, Manufacturing and New Product Introduction (NPI) teams

Duties & Responsibilities:

Key duties, relationships, responsibilities and objectives include:

• Providing product quality support to product development projects, mid-life improvements, customer programs, internal and external manufacturing including: Quality planningFacilitates DFMEA/PFMEAIdentifying and communicating acceptance criteria via Inspection/Test instructions, checklists, etc.Identifying inspection/test instrumentation requirements Product Traceability requirementsFirst Article Test and Inspection (FAT / FAI)Supporting Product Physical and Functional Configuration Audits (PCA/FCA)Process evaluationContract Manufacturer / Supplier training ensuring that acceptance criteria is clearly defined and that appropriate inspections and checks are conducted for deliveries and associated documentation and records are maintained
• Ensures that project QA deliverables comply with applicable corporate policies, processes and/or contractual and/or regulatory requirements
• Trains suppliers and internal inspectors on Med-Eng product, performs product and process audits, analysis of factory and customer inspection yield and performance data
• Follows up to identify corrective actions, coordinates local source inspection with Government Quality Assurance (GQA) or customer’s representative (s) as required
• Performs or co-ordinates off-site acceptance inspections and/or audits of Suppliers and Vendors
• Investigates identified problems or trends, performs root cause analysis and implements correction action plans in a timely manner and coordinates with Technical/Engineering Support or other departments as required
• Act as a point of escalation in support of internal and external manufacturing quality
• Supports the development and review of Compliant Bid documentation (Quality Plans, Supplier Evaluation and Monitoring Plans, etc.)
• Contributes to the Material Review Board (MRB) in assessing disposition alternatives for nonconforming material and the timely completion of NCRs and Corrective Actions
• Provides technical guidance to other employees and assists with the creation and maintenance of quality related documentation
• Other related duties as assigned by the PQ Team Lead, Director of Quality or designate

Qualifications:

• Technical Certificate/diploma in mechanical, electronic or equivalent discipline, or company product knowledge and experience, including strong knowledge of mechanical and electronic assembly, machining, software QA
• Health and Safety training
• ASQ Certified Quality Engineer and / or Auditor preferred
• 5-10 years’ experience in a Quality department in a product development, manufacturing environment
• Familiar with the requirements of ISO 9001 (latest version) based Quality Management system
• Familiar with market product regulatory requirements (CE marking, NIJ, ULC, etc.)
• Strong background in problem solving, data collection and analysis techniques (Lean, 5S, 6 Sigma, 8D, etc.)
• Familiar with inspection, testing and de-risking procedures and methodologies, including First Article Inspections/Test in accordance with AS9012, Design and Process FMEA, PPAP, PCA, FCA, etc.
• Functional computer skills including MS Word, Excel, Access, etc.
• Work cooperatively with others to achieve individual, team and departmental goals
• Be able to interpret technical documents such as drawings and schematic diagrams
• Skilled in analyzing and solving process and product deficiencies
• Strong organizational skills with a good work ethic and the ability to work independently
• The ability to clearly describe, explain and document information, concepts, ideas and instructions to others
• Must be able to travel internationally
• Have a valid driver’s license
• Ability to work independently, manage and organize multiple work activities in order to meet or exceed established deadlines and priorities