The Senior Quality Engineer will be a key driver in implementing managements’ strategic objectives, will have knowledge and experience relating to Quality processes and regulations, and will efficiently perform responsibilities in these areas with minimal supervision. He/She will guide Project teams ensuring that Design Control and product requirements are met and represent the Quality role during the Product Development process and Design Reviews. He/She will provide Quality perspective on Design Verification/Validation study protocols and data analysis incorporating requirements or recommendations from applicable regulatory guidances and consensus standards. The Senior Quality Engineer will identify and improve Quality and Manufacturing processes needing enhancement, provide guidance and support to Manufacturing staff relating to equipment and process validations, perform batch record review and ensure that all activities are performed and documented appropriately. Support Quality System processes e.g. Design Control, Risk Management, CAPAs, NCPRs, Document and Change Control, and Labeling. Mentor and train Manufacturing and Development personnel on Quality System processes and industry standard/best practice.

Provide technical analysis of processes that are involved in the development of products and the manufacturing of products in order to ensure that products developed and manufactured are consistent and meet specifications. Be a knowledgeable resource in IVD product development and ISO/FDA Quality System Requirements for manufacturing and development personnel.

This is an onsite position 

• Provide leadership in the application of Quality Tools in Root Cause Investigations, Designs of Experiments, Stability Studies, Design Verification/Validation and Risk Management.
• Ensure that appropriate procedures are established to support Design Development and the Manufacturing processes. Establish and maintain Design History Files, Device Master Records and other product related documentations in accordance with the Design Control procedures.
• Investigate of process and products failures and implement lasting solutions of such failures.
• Support manufacturing, equipment and validation activities as assigned to ensure that they are well established and compliant with the regulations and quality requirements. Lead manufacturing and development staff in implementation of these processes.
• Identify and lead improvement and lean projects.
• Interface with internal stakeholders to reach consensus solutions to any issues that arise
• Participate in Audits (Internal and External), and Regulatory authority inspections and ensure that risk to company is minimized as much as possible.
• Establish methods to analyze and investigate the root cause of external and internal nonconforming products.
• Support purchasing and receiving controls and work very closely with suppliers of critical components and sub systems. Participate in Supplier Audits.
• Assist in corrective and preventive actions and verifications of effectiveness checks.
• Develop inspection procedures and apply statistical techniques and appropriate sample plans.
• Ensure labeling is compliant
• Gather, analyze, and report data reflecting status of product and processes and provide recommendations to improve such activities. Analyze data from customer complaints, internal audits, internal/external supplier’s data and implement appropriate solutions.
• Participate in Management Reviews.
• Responsible for performing assigned tasks in accordance with applicable safety regulations and instructions, as well as correcting unsafe work habits and practices and/or bringing to the attention of the Safety Team or a supervisor any practice or condition that may be detrimental to the safety and health of the employees. You also have a responsibility to cooperate in all safety or health-related programs and assist in solving safety and health problems. Violations of safety directives and procedures will be handled in accordance with the established Company disciplinary process.
• Perform other duties as assigned.

• Bachelor’s Degree preferred in a life sciences discipline such as: Biochemistry, Chemistry, Microbiology, Biotechnology, Bio-Engineering, Molecular Biology, Animal Sciences, and Toxicology also Manufacturing Engineering, Quality Engineering and Quality Assurance.
• Five to Eight years related experience in IVD, medical, pharmaceutical, or other related industry.
• Must have a thorough understanding of statistical analysis, statistical process control, Investigation and Root Cause Analysis, Corrective and Preventive Action Process, and their application to development and manufacturing processes as a problem identification and resolution tool.
• Proficient in Quality Analysis Tools (Taguchi, Fishbone) & DOE.
• FDA Product and Process Validation Techniques.
• Solid experience in Assay and Consumable/Reagents development in IVD industry.

LANGUAGE SKILLS

Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. Ability to write reports, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public.

 REASONING ABILITY

Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables. Ability to apply mathematical operations to such tasks as frequency distribution, determination of test reliability and validity, analysis of variance, correlation techniques, sampling theory and factor analysis.

CERTIFICATES, LICENSES, REGISTRATIONS

Lean/Six Sigma Greenbelt ASQ Certified Quality Engineer desired

PHYSICAL DEMANDS

While performing the duties of this job, the employee is occasionally required to stand, walk, sit, use hand to finger, handle, feel, reach with hands and arms, climb or balance, stoop, kneel, crouch, or crawl, talk and hear. The employee must occasionally lift and/or move up to 25 pounds. Specific vision requirements involve close vision, distance vision, color vision, peripheral vision, depth perception, and the ability to adjust focus. WORK ENVIRONMENT While performing the duties of this job, the employee is occasionally exposed to moving mechanical parts, fumes or airborne particles, and toxic or caustic chemicals. The noise level in the work environment is usually moderate.

OSHA RISK CATEGORY Category I – tasks which involve exposure

Equal Opportunity Employer: Race/Color/Sex/Sexual Orientation/Gender Identity/Religion/National Origin/Disability/Vets