Job Title: Instrument Quality-Design Engineer
Location: Tucson, AZ (Relocation Package)
Summary: Tucson based manufacturer of diagnostic instrumentation systems is seeking an Instrument Quality-Design Engineer. The incumbent will provide leadership in instrument quality and product design by driving design and process change and engaging in continuous improvement activities. S/he will develop and execute validations for equipment (IOPQs), process (PV), test method (TMV), and cleaning effectiveness. Responsibilities include but are not limited to: inspecting components and assemblies, monitoring First-Pass Yield (FPY), writing verification/validation protocols and reports, revising documentation and drawings to improve product/process quality, performing testing on components and assemblies, reviewing and establishing quality control testing, supporting core team activities, conducting failure investigations, identifying and implementing continuous improvement to processes, capturing and maintaining Operations metrics.
- Daily focus on improving overall instrument Quality and Design
- Lead Instrument Material Review Board activities ensuring proper trending, closure of issues and dispositions are appropriately addressed. Drive continuous improvement initiatives based on MRB data.
- Conduct product design in accordance with project schedule, budget and risks
- Conduct design for manufacturability assessment involving manufacturing expertise to ensure that final design will support projected build quantity, yield, cost and performance requirements
- Lead design reviews, technical assessments and draft engineering changes as required
- Support in the development and maintenance of various quality system documents and records, including batch records, risk files, etc.
- Drive a systematic approach in problem solving and process improvement using quality engineering tools such as Six Sigma, DMAIC, Statistical Process Control, Design of Experiments & Lean manufacturing principles
- Assist in complaint evaluation, coordination of investigations, maintenance of complaint records, and support of regulatory reporting of device incidents and adverse events (AE)
- Define, develop and manage various projects and validation studies to ensure compliance with global regulatory requirements
- Lead Corrective and Preventive Action (CAPA) instrument activities
- Quality Control and Inspect assembly, test, packaging, and delivery documentation and processes
- Write verification procedures, validation protocols, perform inspections and/or tests and prepare reports. SME for third party validation efforts.
- Communicate with development, vendors, purchasing and manufacturing functions regarding new and revised drawings as required
- Bachelor’s degree in Engineering
- 5+ years of design experience, preferably equipment or instrument design & 5+ years of quality engineering experience
- Proficient in Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP) 21 CFR 820, 21 CFR 1271, ISO 13485, ISO 9001, etc.
- Internal and external quality auditing experience is desirable
- Minimum of 2 years Quality experience in an FDA regulated industry or similarly regulated industry
Knowledge, skills and abilities:
- Demonstrate consistent professionalism in customer, cross-team/functional interactions with high concern for customer needs and expectations
- Liaise with suppliers and 3rd party partners
- Have excellent technical and problem-solving skills
- Strong mechanical aptitude
- Experienced with the Microsoft Office software applications for generating office documents, emails, spreadsheets, project plans, etc.
- Ability to clearly and convincingly communicate new ideas, concepts, issues and successes
- Hands-on approach and willingness to support and engage with production personnel
- Demonstrated ability to accomplish goals while working across departments
- Must be able to effectively operate, and manage resources in a fast paced and dynamic environment
- Experience producing and implementing design and test procedures
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