Primary function of the role is to address the backlog of Complaints that resulted from resource issues.
This role supports maintenance and continuous improvement of the Complaint System, ensuring compliance with regulations and internal site and global procedures.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.
Primary responsibilities are to:
Ensure that all complaint investigations are performed, documented, and managed in a timely and efficient manner in accordance with all applicable internal procedures.
Escalate relevant information on product complaints to appropriate management as necessary.
Coordinate and/or attend meetings with appropriate departments for specific customer complaint issues.
Plan, coordinate and execute the onboarding training of new complaint associates.
Assess, process and close complaints in accordance with associated complaint handling procedures and Customer Quality expectations.
Maintain and organize complaint product retention program at the investigation site in accordance with internal procedures and applicable regulatory requirements.
Author and conduct technical complaint evaluations and investigations, including failure analysis.
Review quality and manufacturing records, including DHRs, NCs, CAPAs, complaint records, failure analysis data and reports, and risk documentation as part of the overall complaint investigation process.
Perform trending and risk analysis of received complaint investigations; determine if upper controls have been exceeded and evaluate risk to patient.
Perform robust root cause analysis using appropriate technical skills, structured problem-solving methods, etc.
Review complaint evaluations and investigations, including failure analysis.
Establish, follow, maintain, and improve Quality Management System procedures, work instructions, and other processes related to areas of responsibility.
Support and participate in Internal and External Audits as required.
Ensure compliance with ISO 13485, MDD, 21 CFR 820, GMP, and other applicable regulations and standards related to area of responsibility.
Provide Complaints data analysis for metric reviews as applicable.
Support and participate in post-market surveillance (PMS) activities as required.
Identify and implement opportunities for continuous improvement.
Perform other quality systems related duties as directed by Supervisor.
DESIRED MINIMUM QUALIFICATIONS
Bachelor's degree in an Engineering discipline (ex. - Mechanical, Electrical, etc.) required with minimum of 2-5 years' experience in a regulated (i.e.- Medical Device) industry. Relevant experience may be considered in lieu of a degree.
Strong knowledge of FDA Quality Systems Regulations, GMP, ISO 13485 and other global regulations and standards related to Complaints and Complaint Handling.
Strong verbal and written communication skills with the ability to communicate effectively at multiple levels of the organization.
Demonstrated organizational skills with the ability to multitask, prioritize and meet deadlines.
Must be able to read and write in English.
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.