Senior Quality Engineer

Quest Diagnostics • Marlborough, MA

295d

About The Position

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.

Requirements

• Bachelor's Degree preferred in a life sciences discipline such as Biochemistry, Chemistry, Microbiology, Biotechnology, Bio-Engineering, Molecular Biology, Animal Sciences, and Toxicology.
• Five to Eight years related experience in IVD, medical, pharmaceutical, or other related industry.
• Thorough understanding of statistical analysis, statistical process control, Investigation and Root Cause Analysis, Corrective and Preventive Action Process.
• Proficient in Quality Analysis Tools (Taguchi, Fishbone) & DOE.
• Solid experience in Assay and Consumable/Reagents development in IVD industry.

Nice To Haves

• Lean/Six Sigma Greenbelt certification.
• ASQ Certified Quality Engineer.

Responsibilities

• Guide Project teams ensuring that Design Control and product requirements are met.
• Represent the Quality role during the Product Development process and Design Reviews.
• Provide Quality perspective on Design Verification/Validation study protocols and data analysis.
• 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 involved in product development and manufacturing.
• Lead application of Quality Tools in Root Cause Investigations, Designs of Experiments, Stability Studies, Design Verification/Validation and Risk Management.
• Establish and maintain Design History Files, Device Master Records and other product related documentation.
• Investigate process and product failures and implement lasting solutions.
• Support manufacturing, equipment and validation activities to ensure compliance with regulations and quality requirements.
• Lead manufacturing and development staff in implementation of processes.
• Identify and lead improvement and lean projects.
• Interface with internal stakeholders to reach consensus solutions to issues.
• Participate in Audits (Internal and External) and Regulatory authority inspections.
• Establish methods to analyze and investigate root causes of nonconforming products.
• Support purchasing and receiving controls and work closely with suppliers.
• 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.
• Gather, analyze, and report data reflecting status of product and processes.
• Analyze data from customer complaints, internal audits, and implement appropriate solutions.
• Participate in Management Reviews.
• Perform assigned tasks in accordance with applicable safety regulations and instructions.

Benefits

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

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Industry: Ambulatory Health Care Services
• Education Level: Bachelor's degree