Sr.
Quality Engineer, Instruments
JOB SUMMARY
The Senior Quality
Engineer has responsibility for applying/interpreting the applicable Quality
Systems, developing/implementing the Standard Operating Procedures and policys
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
General:
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.
Qualifications
· 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.
Education:
Bachelors 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.
Compensation
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
