Pilot Operations Senior Quality Engineer
Spectraforce
Irvine, California
23 days ago
Job Description
Title - Pilot Operations Senior Quality Engineer
Duration- 08 Months +
Location - Irvine, CA, 92614
Job Description Summary
This Pilot Operations Senior Quality Engineer role partners on the development of delivery systems for clinical manufacturing for the Transcatheter Heart Valve (THV) Business Unit.
Job Description
Imagine how your ideas and expertise can change a patient’s life. Our Quality team helps shape the development of groundbreaking technologies to ensure each stage of the innovation process is held to the highest standards of integrity and safety. You’ll bring your passion for problem-solving and partner with various teams to influence decision-making for a product’s entire lifecycle. Your work will enable you to optimize product development to impact patients around the world with pioneering technology.
Aortic stenosis impacts millions of people globally, yet it often remains underdiagnosed and under-treated. groundbreaking work in transcatheter aortic heart valve replacement (TAVR) pioneered an innovative, life-changing solution for patients by offering heart valve replacement without the need for open heart surgery. Our Transcatheter Heart Valve (THV) business unit continues to partner with cardiologists and clinical teams to transform patient care with devices supported by clinical evidence. It’s our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey.
This Pilot Operations Sr Quality Engineer role starts with the opportunity to partner on the development of delivery systems for the Transcatheter Heart Valve (THV) Business Unit as a part of the Global Supply Chain. This cross functional partner will (1) interact with various functional departments to accomplish compliance and implementation of quality goals with a primary focus on quality operations for Pilot manufacturing, (2) work with THV new product development teams in the manufacturing of products for feasibility studies, quality system test samples, Early Human Use, and clinical studies and (3) support product transfer from Pilot manufacturing to receiving site manufacturing facilities.
Key Responsibilities:
• Work with new product development teams to help them efficiently navigate the Quality System to build quality system test samples and human use products according to project schedules
• Identify and ensure implementation of opportunities to optimize/improve manufacturing and inspection processes
• Perform risk assessment on early-stage product manufacturing processes (e.g., PFMEAs, Live Manufacturing Process Reviews)
• Analyse and resolve complex manufacturing and compliance issues (e.g., CAPA, non-conformances, audit observations)
• Develop/drive improvements for inspection test methods
• Lead test method validation activities for in-process inspections
• Facilitate and oversee Material Review Board to disposition potentially non-conforming human use products
• Track product yields and defect rates. Use data to report metrics at Quality Data Reviews and drive process improvements
Education and Experience:
• Prior experience in medical device manufacturing or operations preferred
• Experience with computerized Manufacturing Execution System (MES) preferred
• Bachelor's Degree in relative Engineering field plus minimum of four (4) years medical device industry experience required
• Master's Degree in relative Engineering field plus minimum of three (3) years medical device industry experience required
Additional Skills & Expectations:
• Strict attention to detail
• Substantial understanding and knowledge of principles, theories, and concepts relevant to Quality Engineering
• Strong problem-solving, analytical, and critical thinking skills
• Exhibits professional communication (e.g., written and verbal) and interpersonal relationship skills including consultative and relationship management
• Ability to manage competing priorities in a fast-paced environment
• Thrives in a collaborative team environment, including inter-departmental teams and key contact representing the organization on contracts or projects
• Advanced knowledge of statistical techniques and analytics (experience in Minitab preferred)
• Demonstrates strong leadership skills and ability to influence change
• Knowledge of applicable FDA regulations for medical device industry
• Ability to interact professionally with all organizational levels, including Sr Management, cross functional teams and external partners
About Us: Established in 2004, SPECTRAFORCE® is one of the largest and fastest-growing diversity-owned staffing firms in the US. The growth of our company is a direct result of our global client service delivery model that is powered by our state-of-the-art A.I. proprietary talent acquisition platform, robust ISO 9001:2015/ISO 27001 certified processes, and strong and passionate client engaged teams. We have built our business by providing talent and project-based solutions, including Contingent, Permanent, and Statement of Work (SOW) services to over 140 clients in the US, Canada, Puerto Rico, Costa Rica, and India. Key industries that we service include Technology, Financial Services, Life Sciences, Healthcare, Telecom, Retail, Utilities and Transportation. SPECTRAFORCE is built on a concept of “human connection,” defined by our branding attitude of NEWJOBPHORIA®, which is the excitement of bringing joy and freedom to the work lifestyle so our people and clients can reach their highest potential. Learn more at: http://www.spectraforce.com
Benefits: SPECTRAFORCE offers ACA compliant health benefits as well as dental, vision, accident, critical illness, voluntary life, and hospital indemnity insurances to eligible employees. Additional benefits offered to eligible employees include commuter benefits, 401K plan with matching, and a referral bonus program. SPECTRAFORCE provides unpaid leave as well as paid sick leave when required by law.
Equal Opportunity Employer: SPECTRAFORCE is an equal opportunity employer and does not discriminate against any employee or applicant for employment because of race, religion, color, sex, national origin, age, sexual orientation, gender identity, genetic information, disability or veteran status, or any other category protected by applicable federal, state, or local laws. Please contact Human Resources at LOA@spectraforce.com if you require reasonable accommodation.
California Applicant Notice: SPECTRAFORCE is committed to complying with the California Privacy Rights Act (“CPRA”) effective January 1, 2023; and all data privacy laws in the jurisdictions in which it recruits and hires employees. A Notice to California Job Applicants Regarding the Collection of Personal Information can be located on our website. Applicants with disabilities may access this notice in an alternative format by contacting NAHR@spectraforce.com.
LA County, CA Applicant Notice: If you are selected for this position with SPECTRAFORCE, your offer is contingent upon the satisfactory completion of several requirements, including but not limited to, a criminal background check. We consider qualified applicants with arrest or conviction records for employment in accordance with all local ordinances and state laws, including the Los Angeles County Fair Chance Ordinance for Employers (FCO) and the California Fair Chance Act (FCA). The background check assessment will consider whether a criminal history could reasonably have a direct, adverse impact on the job-related safety, security, trust, regulatory compliance, or suitability for this role. Such findings may result in withdrawal of a conditional job offer.
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $50.00/hr.
Duration- 08 Months +
Location - Irvine, CA, 92614
Job Description Summary
This Pilot Operations Senior Quality Engineer role partners on the development of delivery systems for clinical manufacturing for the Transcatheter Heart Valve (THV) Business Unit.
Job Description
Imagine how your ideas and expertise can change a patient’s life. Our Quality team helps shape the development of groundbreaking technologies to ensure each stage of the innovation process is held to the highest standards of integrity and safety. You’ll bring your passion for problem-solving and partner with various teams to influence decision-making for a product’s entire lifecycle. Your work will enable you to optimize product development to impact patients around the world with pioneering technology.
Aortic stenosis impacts millions of people globally, yet it often remains underdiagnosed and under-treated. groundbreaking work in transcatheter aortic heart valve replacement (TAVR) pioneered an innovative, life-changing solution for patients by offering heart valve replacement without the need for open heart surgery. Our Transcatheter Heart Valve (THV) business unit continues to partner with cardiologists and clinical teams to transform patient care with devices supported by clinical evidence. It’s our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey.
This Pilot Operations Sr Quality Engineer role starts with the opportunity to partner on the development of delivery systems for the Transcatheter Heart Valve (THV) Business Unit as a part of the Global Supply Chain. This cross functional partner will (1) interact with various functional departments to accomplish compliance and implementation of quality goals with a primary focus on quality operations for Pilot manufacturing, (2) work with THV new product development teams in the manufacturing of products for feasibility studies, quality system test samples, Early Human Use, and clinical studies and (3) support product transfer from Pilot manufacturing to receiving site manufacturing facilities.
Key Responsibilities:
• Work with new product development teams to help them efficiently navigate the Quality System to build quality system test samples and human use products according to project schedules
• Identify and ensure implementation of opportunities to optimize/improve manufacturing and inspection processes
• Perform risk assessment on early-stage product manufacturing processes (e.g., PFMEAs, Live Manufacturing Process Reviews)
• Analyse and resolve complex manufacturing and compliance issues (e.g., CAPA, non-conformances, audit observations)
• Develop/drive improvements for inspection test methods
• Lead test method validation activities for in-process inspections
• Facilitate and oversee Material Review Board to disposition potentially non-conforming human use products
• Track product yields and defect rates. Use data to report metrics at Quality Data Reviews and drive process improvements
Education and Experience:
• Prior experience in medical device manufacturing or operations preferred
• Experience with computerized Manufacturing Execution System (MES) preferred
• Bachelor's Degree in relative Engineering field plus minimum of four (4) years medical device industry experience required
• Master's Degree in relative Engineering field plus minimum of three (3) years medical device industry experience required
Additional Skills & Expectations:
• Strict attention to detail
• Substantial understanding and knowledge of principles, theories, and concepts relevant to Quality Engineering
• Strong problem-solving, analytical, and critical thinking skills
• Exhibits professional communication (e.g., written and verbal) and interpersonal relationship skills including consultative and relationship management
• Ability to manage competing priorities in a fast-paced environment
• Thrives in a collaborative team environment, including inter-departmental teams and key contact representing the organization on contracts or projects
• Advanced knowledge of statistical techniques and analytics (experience in Minitab preferred)
• Demonstrates strong leadership skills and ability to influence change
• Knowledge of applicable FDA regulations for medical device industry
• Ability to interact professionally with all organizational levels, including Sr Management, cross functional teams and external partners
About Us: Established in 2004, SPECTRAFORCE® is one of the largest and fastest-growing diversity-owned staffing firms in the US. The growth of our company is a direct result of our global client service delivery model that is powered by our state-of-the-art A.I. proprietary talent acquisition platform, robust ISO 9001:2015/ISO 27001 certified processes, and strong and passionate client engaged teams. We have built our business by providing talent and project-based solutions, including Contingent, Permanent, and Statement of Work (SOW) services to over 140 clients in the US, Canada, Puerto Rico, Costa Rica, and India. Key industries that we service include Technology, Financial Services, Life Sciences, Healthcare, Telecom, Retail, Utilities and Transportation. SPECTRAFORCE is built on a concept of “human connection,” defined by our branding attitude of NEWJOBPHORIA®, which is the excitement of bringing joy and freedom to the work lifestyle so our people and clients can reach their highest potential. Learn more at: http://www.spectraforce.com
Benefits: SPECTRAFORCE offers ACA compliant health benefits as well as dental, vision, accident, critical illness, voluntary life, and hospital indemnity insurances to eligible employees. Additional benefits offered to eligible employees include commuter benefits, 401K plan with matching, and a referral bonus program. SPECTRAFORCE provides unpaid leave as well as paid sick leave when required by law.
Equal Opportunity Employer: SPECTRAFORCE is an equal opportunity employer and does not discriminate against any employee or applicant for employment because of race, religion, color, sex, national origin, age, sexual orientation, gender identity, genetic information, disability or veteran status, or any other category protected by applicable federal, state, or local laws. Please contact Human Resources at LOA@spectraforce.com if you require reasonable accommodation.
California Applicant Notice: SPECTRAFORCE is committed to complying with the California Privacy Rights Act (“CPRA”) effective January 1, 2023; and all data privacy laws in the jurisdictions in which it recruits and hires employees. A Notice to California Job Applicants Regarding the Collection of Personal Information can be located on our website. Applicants with disabilities may access this notice in an alternative format by contacting NAHR@spectraforce.com.
LA County, CA Applicant Notice: If you are selected for this position with SPECTRAFORCE, your offer is contingent upon the satisfactory completion of several requirements, including but not limited to, a criminal background check. We consider qualified applicants with arrest or conviction records for employment in accordance with all local ordinances and state laws, including the Los Angeles County Fair Chance Ordinance for Employers (FCO) and the California Fair Chance Act (FCA). The background check assessment will consider whether a criminal history could reasonably have a direct, adverse impact on the job-related safety, security, trust, regulatory compliance, or suitability for this role. Such findings may result in withdrawal of a conditional job offer.
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $50.00/hr.