The Sr. Quality Engineer will utilize Quality Engineering tools and practices for the effective and efficient development, transfer and maintenance of products/processes throughout the product lifecycle. The individual will also utilize Quality Engineering principles and problem-solving skills to improve and maintain products/processes that are aligned with the overall Quality and Business vision. The individual will utilize appropriate risk management to prevent unanticipated failure modes and improve capability of processes. This person will support processes in base business and supervise, lead and mentor other engineers and technicians.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
Support quality improvement initiatives such as process and product characterizations that lead to continuous / cost improvements. • Work on non-conforming (NC) reports (Initiate, Analysis, Investigation, Review and close). • Work with third party supplier to resolve issues with NC. • Conduct Internal/Supplier Audits of the facility per ISO-1385 and/or 21CFR820 • Develop, interpret and implement appropriate process monitoring and control methods consistent with the level of process/product risk. • Collect data and execute/conduct various analytical/statistical analysis and interpretation as part of process improvements and day-to-day support. • Conduct investigation, bounding, documentation, review and approval of nonconformances, CAPAs and customer complaints. Escalation of quality issues as appropriate. • Accountability and ownership for material identification, material segregation, classification of defect types including the successful application of these techniques on a day-to-day basis in manufacturing. • Analyze/review effectiveness of preventive and corrective actions. Review root cause investigation according to an established process.
It is also understood that an associate may receive special projects outside of this list.
DESIRED MINIMUM QUALIFICATIONS: • Minimum required education and experience: Bachelor's degree or equivalent with 8+ years of experience, master's degree with 5+ years of experience, Doctoral degree with 3+ years of experience • This position will require relevant experience working in manufacturing/operations. • In-depth knowledge of product/process Risk Management (FDA and ISO standards) is required. • Experience with a proven track record of implementing appropriate risk mitigation. • Certified Internal Audit to ISO-13485. • Advanced knowledge and experience in the areas listed in the Duties and Responsibilities associated with the position.
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.