Principal Quality Engineer

Katalyst Healthcares and Life Sciences

Job Description:

We are seeking an experienced Principal Quality Engineer to lead quality engineering initiatives that ensure compliance, product quality, and continuous improvement across manufacturing and product development processes. The ideal candidate will provide technical leadership in quality systems, risk management, validation, CAPA, supplier quality, and regulatory compliance while partnering with cross-functional teams to drive operational excellence.

Responsibilities:

Lead quality engineering activities supporting product development, manufacturing, and sustaining engineering.
Develop and implement quality strategies that comply with FDA, ISO 13485, ISO 9001, and other applicable regulatory requirements.
Drive root cause investigations and corrective and preventive actions (CAPA) using structured problem-solving methodologies.
Lead risk management activities including DFMEA, PFMEA, risk assessments, and mitigation plans.
Review and approve engineering change orders (ECOs), design documentation, validation protocols, and quality records.
Support design control activities including Design Verification & Validation (V&V), Design Reviews, and Design History Files (DHF).
nalyze quality metrics and implement continuous improvement initiatives using Lean Six Sigma and statistical tools.
Lead process validation activities including IQ, OQ, PQ, and process capability studies.
Collaborate with Manufacturing, R&D, Regulatory Affairs, Supply Chain, and Operations to resolve quality issues.
Provide technical leadership during internal, customer, and regulatory audits.
Mentor and coach Quality Engineers and cross-functional teams on quality best practices.
Support supplier qualification, supplier audits, and supplier quality improvement initiatives.
Ensure compliance with cGMP, FDA Quality System Regulation (21 CFR Part 820/QMSR), and applicable international standards.

Requirements:

Bachelor's degree in Engineering (Mechanical, Biomedical, Industrial, Manufacturing, Electrical, Chemical, or related discipline).
8+ years of Quality Engineering experience in a regulated manufacturing environment.
Strong knowledge of FDA regulations, ISO 13485, ISO 9001, and cGMP requirements.
Experience with Design Controls, Risk Management (ISO 14971), CAPA, Client, and change management.
Hands-on experience with process validation (IQ/OQ/PQ), statistical analysis, SPC, MSA, and capability studies.
Strong knowledge of Lean Manufacturing, Six Sigma, and continuous improvement methodologies.
Excellent root cause analysis skills utilizing 8D, Fishbone, 5 Whys, and similar tools.
Experience leading cross-functional projects and mentoring engineering teams.
Strong written, verbal, and presentation skills.

Preferred Qualifications:

Master's degree in Engineering or related technical field.
SQ Certified Quality Engineer (CQE), Six Sigma Green Belt or Black Belt.
Experience in medical devices, pharmaceuticals, biotechnology, aerospace, automotive, or other highly regulated industries.
Experience supporting FDA inspections and ISO certification audits.
Knowledge of validation documentation, statistical software (Minitab), and quality management systems.

Apply

Vacancy posted 4 days ago

Similar jobs that could be interesting for youBased on the Principal Quality Engineer in Spokane, WA vacancy

Principal Engineer
Job Posting Location: 129 W. Main St., Solomon, KS, 67480, United States Job Category: Sunbelt Solomon Employee Type: Exempt - FT Required Degree: 4 Year Degree Travel: 15% Manage Others: No Minimum Experience: 5 Years Contact Information Name...
Suggested
Sunbelt Solomon
Spokane, WA
2 days ago
Security & Compliance Engineer
...compensation is based on various factors including but not limited to job location, a candidate's education, training, experience, expected quality and quantity of work, required travel (if any), external market and internal value analysis including seniority and merit systems,...
Suggested
Minimum wage
Contract work
Temporary work
Work experience placement
Remote work
MAXIMUS
Spokane, WA
3 days ago
Civil Engineering Project Manager
...Civil Engineering Project Manager Ready to take your engineering career to the next level? DCI Engineers is seeking a Civil Engineering Project Manager in our Spokane, WA office. You'll apply your civil engineering degree and hands-on experience to lead complex building...
Suggested
Temporary work
For contractors
Work at office
D'Amato Conversano Inc.,P.C.
Spokane, WA
1 day ago
Engineering Manager - Substation
$181k - $218k
...Engineering Manager - Substation The Engineering Manager - Substation will provide engineering expertise and technical support throughout... ...schedule while ensuring cost-effective solutions. Oversee quality control procedures to ensure the highest standards of...
Suggested
For contractors
Local area
Quanta Infrastructure Solutions Group, LLC
Spokane, WA
14 hours ago
General Engineer
...General Engineer As a General Engineer, you will: Design, initiate, and conduct basic and applied research addressing mining health and safety issues. Lead and perform field and laboratory investigations, data collections, and technical assessments aimed at reducing...
Suggested
For contractors
Department Of Health And Human Services
Spokane, WA
14 hours ago
Principal Water Resources Engineer or Hydrogeologist/Geologist
$150k - $205k
...close-knit team that values collaboration, responsiveness, and quality.Flexibility: Enjoy a hybrid work schedule in one of the... ...Qualifications:Bachelor’s or Master’s degree in hydrogeology, geology, engineering, or a related field 10+ years of relevant experience in water...
Work at office
Local area
Remote work
Flexible hours
Landau Associates
Spokane, WA
3 days ago
Director of Engineering - Pharma Aseptic Filling
$300k
...growing BioPharma CDMO company needs a Director of Equipment Engineering at their expanding plant in WA state. Excellent total comp.... ...activities, ensuring adherence to design intent and quality standards Compliance & Quality: Serve as the primary engineering...
Contract work
For contractors
Relocation
Relocation package
Night shift
MRINetwork Jobs
Spokane, WA
2 days ago
General Engineer
...Qualifications WHAT WE ARE LOOKING FOR Basic Qualifications: A. Degree: Engineering. To be acceptable, the program must: (1) lead to a bachelor's... ...a difference in the lives of Americans everywhere. It is the principal agency for protecting the health of citizens. Join HHS and...
Full time
Part time
Internship
Work at office
Centers for Disease Control and Prevention
Spokane, WA
5 days ago
Test Engineering Manager
$100k - $125k
...Test Engineering Manager Spokane - Spokane Valley, WA 99216 Overview Salary Range $100,000.00 - $125,000.00 Salary/year Position... ...unobstructed work area Provide customers with the highest quality of products and service Understand and apply appropriate quality...
Full time
Contract work
Temporary work
Work at office
Shift work
Day shift
Keytronic
Spokane, WA
2 days ago
: Associate Director of Engineering - Pharma Aseptic Filling
$250k
...growing BioPharma CDMO company needs an Associate Director of Engineering at their expanding plant in WA state, Excellent total comp.... .... # Collaborate with cross-functional teams (Manufacturing, Quality, Validation) to ensure equipment meets process and regulatory...
Contract work
For contractors
Relocation
Relocation package
Night shift
MRINetwork Jobs
Spokane, WA
2 days ago
Professional Engineer - Senior Drainage Engineer / Project Manager
...responsibility to the communities where we live and work. As a Drainage Engineer / Project Manager, you will be involved in projects with our... ...hydraulic analyses, technical drainage report preparation, and quality assurance/quality control (QA/QC) review of various...
Hourly pay
Work at office
Local area
Horrocks
Spokane, WA
2 days ago
Reliability Test Engineer
Keytronic in Spokane Valley, WA is seeking a Reliability Electronics Technician to develop and execute reliability and environmental test plans for production development, process development and outside business. You will create data graphs and reports to support customer...
Keytronic
Spokane, WA
2 days ago
Professional Electrical Engineer - Senior | Project Manager
$125k - $160k
...Professional Electrical Engineer - Senior | Project Manager Location: Coeur d'Alene, ID | Spokane, WA | Kennewick, WA or other J-U-... ...team environment, and take pride in delivering accurate, high-quality work that helps drive business success, we'd love to meet you!...
For contractors
Work at office
J-U-B Engineers
Spokane, WA
14 hours ago
Director of Operations
$81k
...Build the engine behind a growing home care agency We’re not looking for someone to maintain what already exists. We’re looking for someone who sees how things could run better… and actually builds the systems to make it happen. Our agency is growing. Referrals are increasing...
Work at office
Angel Senior Care
Spokane, WA
4 days ago
Operations Supervisor
$75.55k - $94.44k
...section in a service center while maintaining and achieving the department/shift and service center and/or company standards for safety, quality, efficiency, cost, service and delivery, training and development and housekeeping. Responsibilities: Monitors and...
Hourly pay
Full time
Temporary work
Work at office
Local area
Monday to Friday
Shift work
Day shift
Old Dominion Freight
Spokane, WA
1 day ago
HVAC Operations Manager
$45 - $55 per hour
...departments to ensure successful project delivery Support hiring, onboarding, and employee development Maintain high standards for safety, quality, and customer satisfaction Required Qualifications 5+ years of leadership experience in commercial or industrial HVAC operations...
Hourly pay
Work at office
Legacy Heating & Cooling
Spokane, WA
9 hours ago
Director Clinical Operations and Medical Policy
$179.4k - $242.7k
...healthcare professionals and key vendors including the Pharmacy Benefit Manager (PBM) to optimize programs supporting medication access, quality, and affordabilityEnsure ongoing evaluation and quality improvement of evidence-based medication technology assessment methods,...
Full time
Work at office
Immediate start
Work from home
Relocation
Flexible hours
3 days per week
Cambia Health Solutions
Spokane, WA
14 hours ago
Finance Manager - Regional Finance Operations - Full time, Day, Onsite
Providence is calling a Finance Manager at Providence Sacred Heart Medical Center in Washington. The Finance Manager support local ministry/entity leadership teams and may serve on local leadership committees as assigned. Responsible for financial analysis and modeling ...
Minimum wage
Full time
Local area
Shift work
Providence Health & Services
Spokane, WA
1 day ago
Operations Manager
$40 per hour
Description The Operations Manager/Delivery Lead role is a key role within TEKsystems Global Service’s (TGS) organization and functions in the execution of day-to-day activities in support of multiple customer engagements. A successful Operations Manager/Delivery Lead...
Contract work
Temporary work
Shift work
TEKsystems
Spokane, WA
1 day ago
Operations Manager
$22.13 - $36.13 per hour
...be surrounded by passionate colleagues who care deeply, innovate with purpose, hold ourselves accountable and prioritize safety and quality in everything we do. Join us and be part of something bigger – helping to simplify health care one person, one family and one...
Hourly pay
Full time
Temporary work
Flexible hours
Shift work
Night shift
Weekend work
Day shift
Early shift
CVS Health
Spokane, WA
1 day ago
Operations Manager
...during their shifts to maintain the highest levels of safety, quality, attendance, and performance. To achieve this, managers are expected... ...promises Collaborate with all support teams including Safety, Engineering, Loss Prevention, Quality Assurance, Human Resources to...
Hourly pay
Remote work
Shift work
Amazon
Spokane, WA
14 hours ago
Operations Manager
...housekeeping in work area. Demonstrates strong commitment to safety, quality, environmental awareness, and continuous process improvement.... ...States – and one of the largest manufacturers of plywood and engineered wood products in North America. Because our business is built...
Work experience placement
Seasonal work
Work at office
Flexible hours
Boise Cascade Company
Spokane, WA
15 days ago
☀️ Operations Manager ????
...???? - **Budgeting Buff:** You manage office budgets like a champ, tracking expenses while optimizing costs without sacrificing quality! ???? **2. Industry Knowledge and Experience** - **Plumbing Aficionado:** If you have experience in the plumbing or trade industry...
Part time
Work at office
Local area
Action Craft Experts
Spokane, WA
16 days ago
Bridge Engineer Project Manager
$115k - $150k
KPFF, a multi-office, multi-discipline engineering firm, is committed to Excellence, Trust, Relationships, Stability, and Passion. For over 65 years KPFF has been providing creative solutions and excellent client service for a diverse range of projects and industries. Our...
Temporary work
For contractors
Work at office
Local area
Flexible hours
KPFF Inc.
Spokane, WA
1 day ago
National Manager, Infrastructure & Operations
$175k - $190k
...performance.Partner closely with Service Desk, Site Services, Engineering, Cybersecurity, Applications, and Construction Technology teams... ...indicators that measure operational effectiveness, service quality, automation maturity, financial efficiency, security control performance...
Full time
Temporary work
Flexible hours
Swinerton
Spokane, WA
4 days ago
Legal Operations Specialist
$37.4 - $56.1 per hour
...Department operates with efficiency, transparency, accountability, and strong financial discipline while enabling the team to deliver high-quality legal services across the organization. The ideal candidate blends legal knowledge, operational excellence, financial acumen,...
Hourly pay
Contract work
Local area
Washington Trust Bank Careers
Spokane, WA
2 days ago
Operations Specialist
Spokane Public Facilities District is seeking seasonal staff to handle event setup and strike for a variety of district facilities. You will perform setup, teardown, maintenance tasks, and operate equipment to enable maximal facility use during events. Hours vary weekly...
Odd job
Seasonal work
Spokane Public Facilities District
Spokane, WA
4 days ago
Operations Specialist
$21 - $23 per hour
Operations Specialist ApplyRefer a FriendBack Job Details Requisition #: 216005 Location: Spokane, WA 99206 Category: Business Operations Salary: $21.00 - $23.00 per hour Position Details Position Overview As an Operations Specialist,...
Hourly pay
Work at office
Aveanna Healthcare LLC
Spokane, WA
14 hours ago
Operations Specialist
$80k
...strategies Help optimize inventory, pricing, and product offerings Plan and support quarterly sales events and promotions Ensure Quality & Compliance Conduct operational audits focused on workflow, cycle times, and service quality Monitor adherence to safety,...
Work at office
Local area
Night shift
HRU Technical Resources
Spokane, WA
1 day ago
Security Operations Shift Lead
...compensation is based on various factors including but not limited to job location, a candidate's education, training, experience, expected quality and quantity of work, required travel (if any), external market and internal value analysis including seniority and merit systems,...
Minimum wage
Contract work
Temporary work
Work experience placement
Remote work
Shift work
MAXIMUS
Spokane, WA
3 days ago

Do you want to receive more vacancies?

Subscribe and receive similar vacancies to Principal Quality Engineer. Be the first to apply!