Senior Quality Engineer

The primary purpose of this position is to apply intensive and diversified knowledge of engineering principles and practices in broad areas of assignments and related fields.

You will ensure that Integer internal and external customers’ expectations are met or exceeded.

Adheres to Integer Core Beliefs and all safety and quality requirements including, but not limited to : Quality Management Systems (QMS), Environmental Management Systems (EMS), U.

S. Food and Drug Administration (FDA) regulations, Company policies and operating procedures, and other regulatory requirements.

• Supports regulatory and agency inspections, audits, investigations, and inquiries regarding the control and assessment of product design and manufacturing quality.
• Ability to interpret drawings, product / performance specifications, and other systems integration technical data
• Monitors manufacturing of assigned products, assuring compliance with DMR and quality system requirements and assuring complete and correct Device History Records are maintained.
• Leads product and process improvement initiatives.
• Implements various product and process improvement methodologies
• Reviews the adequacy and correctness of changes to Bill of Materials (BOM’s), Assembly Procedures, Drawings, Component Specification, FMEAs, Control Plans, etc.
• Leads in the development, completion, and maintenance of risk analyses.
• Leads generation and completion of protocols and reports for product, process, and test method validations.
• Interfaces with Manufacturing Engineers to review processes for new and existing products and coordinate process validations and capability studies.

Recommends process monitoring devices where applicable.

• Develops various inspection techniques and procedures to ensure product integrity to design specifications. Responsible for the writing, approval and implementation of Incoming, In-Process and Final Inspection procedures.
• Ensures that the disposition of non-conforming materials meet all necessary regulatory requirements and assure adequacy of corrective actions to prevent re-occurrence.
• Leads and manage complaint investigations and remediation recommendations as needed.
• Leads plant CAPA activities, including analysis of data and trends in complaints, supplier quality, nonconforming material, training effectiveness, and root causes analysis.
• Assists with product transfers.
• Works with suppliers, management, Engineers and Manufacturing associates in the resolution of quality problems through capability studies and the application of statistical quality control which include Cpk, DOE, Hypotheses Testing, etc.
• Provides technical support to and work direction other Quality Engineers as needed.
• Opportunity to lead Quality Techician exists if your IDP includes People management experience

How you will be measured :

• The specific measures listed below may be subject to change and are not intended to be an all-inclusive list
• Safety is our highest priority; you will be an active supporter of the Integer Environmental, Health & Safety programs.
• Quality Achievement of site Quality KPI’s
• You will have defined Goals and Objectives specifying key projects and expected milestones to achieve.
• Given your capabilities and experience, you will be expected to identify ways to shorten project durations and lead systemic changes to current processes and procedures that enable greater efficiencies.
• Innovation and ideation are critical aspects of your role and you will be expected to generate continuous improvement suggestions and support the implementation of them.
• Your expertise coupled with your accomplishments and collaboration with others to deliver results will also be considered.

What sets you apart :

• You have earned, as a minimum, a Bachelor’s Degree in an engineering or related technical field. Preferably, you may also have a Master’s Degree or a Doctorate.
• You are technically seen as a subject matter expert, a recognition you have earned through 7+ years of progressive engineering and / or technically focused roles and experiences.
• Candidates who do not meet the education requirement may be considered with 15+ years of relevant experience.
• You have a strong technical and problem solving foundation, and preferably training and certifications, in a variety of problem-solving and project management methodologies such as 6-Sigma (green belt as a minimum, black belt preferred), 8D, RCA, 5-Why, Ishikawa (Fish Bone), Kepner-Tregoe, PMP.
• Your abilities to observe, analyze and develop solutions to complex technical challenges result in the delivery of break-through results in areas such as productivity, technical capabilities, capacities, or other competitive differentiators.
• You work independently as well as collaboratively with cross functional teams.
• You will demonstrate the ability to lead team activities and act as a coach for other less experienced associates.
• Clear and professional communications to all levels of the organization are important in this role and you will have well-developed written and oral communication skills.
• You maintain a calm demeanor that transcends the high energy, constantly changing production environment.
• You possess a positive, can-do attitude with an underlying belief that failure is not an option.

U.S. Applicants : EOE / AA Disability / Veteran