Sr. Quality Engineer, Instruments



The Senior Quality Engineer has responsibility for applying/interpreting the applicable Quality Systems, developing/implementing the Standard Operating Procedures and policy’s for an organization, such as Quality control, or a manufacturing plant. Develops and maintains schedules and timelines. Ensures the documentation process remains compliant..


The role provides guidance for the various elements of the Quality System, for example, to ensure process control, consistent supplier qualification practices and identifies/recommends opportunities for continuous improvement (internal/external). Applies the appropriate statistical tools to analyze data, identify root cause and corrective actions for effective problem resolution of moderate to difficult scope and complexity. May support both internal and external audits by assuming the Lead Auditor role


Responsibilities include monitoring and trending quality indicators for purchased materials as well as manufactured and distributed components/products. Assesses Critical To Quality (CTQ) parameters and risk assessment variables as part of the decision making processes to support predictable product design and flow. Initiates CAPAs and may lead the investigation/corrective action process.


Knowledgeable in specific automated systems as noted and engaged in new product introductions as a possible Core Team member representing the Quality function.


DUTIES and responsibilities




Responsible for all aspects (product and process) related to the quality of the Instrument Plant for the designated product line(s). This includes manufacturability of products at the Instrument Plant, supplier manufacturing, customer requirements and complaints.  The Senior Quality Engineer will be responsible for developing and maintaining the Design History File, product and supplier quality.  Develops, modifies, applies and maintains quality standards and protocols.


General Responsibilities include:

1.  Maintain FDA (Food & Drug Administration) and ISO (International Organization for Standardization) regulatory requirements. Key elements of focus are (but not limited to) product design for manufacturability, customer complaints, assembly and test, inspection and validation throughout the development process.

2. Generate process/product quality information in the form of Critical to Quality indices and share with project team/operations recommendations and solutions to emerging issues.


3. Lead product quality analysis for total system, including instrument, disposables and reagents.

4. Improve key quality metrics (Fist Pass Acceptance, Quality Notifications and Complaint data).

5. Develop department programs / processes on continuous improvement and standardization across the  Diagnostic Systems.

6. Supports the coordinated integration of new products into Manufacturing / Operations.

7. Ensures Diagnostic Systems divisional, departmental policies, procedures, practices and facilities are in compliance with all applicable regulatory policies.

8. Develop Design / Device History Files and maintain in a manner consistent with FDA (Food and Drug Administration) requirements

9. Understanding of Quality Systems and procedures

10.Other emerging responsibilities as identified and assigned.




· Ability and skill to effectively manage multiple tasks and drive execution of change management plans

· Ability to look at therapy / process level view of total system impact, and go beyond viewing only the instrument in evaluating product operation.

· Ability and skill to lead or manage process control, supplier quality and continuous improvement projects using statistical technique/tools such as: Statistical sampling, SPC

Six sigma, additionally root cause analysis and project management techniques are routinely employed

· Ability to effectively write communications that ensures clarity, accuracy and consideration of the audience

· Ability to speak with clarity and express points of view in a variety of settings; one-on-one interactions, group meetings, and formal presentations

· Ability to listen to others; including associates, managers, peers and customers when making decisions and solving problems

· Ability and skill to analyze data using systematic analytical tools such as Six Sigma, root cause analysis, failure analysis and risk assessment to gather critical information that has moderate to difficult complexity

· Ability to drive for results and effectively work through conflicts in working teams by facilitating conflict resolution

· Sound workable knowledge and understanding of the Food and Drug Administration (FDA) 21 CFR 820 and International Organization for Standardization (ISO) ISO 9000:2000 and ISO 13485:2003

· Professional certification preferred.  Six Sigma, ASQ, AAMI

· Experienced in Microsoft Office suite skills.  Basic mini tab and/or related analytical software programs

Preferred:  Certification such as ASQ-CQA/CQE, AAMI, Six Sigma or a Company certification such as Green Belt, Black Belt, IGQA auditor.




Bachelor’s degree with 5 years of experience in a regulated environment or MS with 3 years of experience. Typical degree in Electrical or Mechanical or Industrial Engineering.


BS in related field required with minimum of 3 years of Quality Operations or Regulatory experience in the medical device environment or 5 years in manufacturing environment or MS with 3 years of experience. Typical degree in Mechanical or Electrical or Industrial Engineering, Biological Sciences, Chemistry, and/or Computer Science or other related field. Experience and understanding of electro-mechanical instrumented systems. Professional certifications such as Certified Quality Auditor/Certified Quality Engineer, Six Sigma preferred.


Benefits - Full 
Relocation Assistance Available - Yes 
Bonus Eligible - Yes 

Candidate Details
5+ to 7 years experience
Minimum Education - Bachelor's Degree
Willingness to Travel - Occasionally