QA Complaint Specialist III

QA Complaint Specialist III

Grifols Diagnostic Solutions is seeking a QA Complaints Specialist III. The QA Complaints Specialist III runs assays to support investigations, performs investigation into NAT assay related complaints, participates in CAPAs and performs work related to their area of expertise (including but not limited to assisting in MDR reporting and Audit). This role also maintains laboratory equipment and works collaboratively with interdepartmental teams to ensure investigations are completed and closed out in a timely manner.

We are seeking individuals with a bachelor's degree and a minimum of 8 years of relatable experience. Candidates must have work experience in handling and investigation in a regulated setting. Experience in technical writing and trend analysis is preferred.

Responsibilities

• Independently conduct complex complaint investigations through interfacing with field reps. to acknowledge, document, analyze information and data, perform deeper investigation into root causes, and assign additional actions as necessary to close the complaint.
• Leads CAPA investigations and actions, including planning, drafting / approving protocol and design experiments, execution, and effectiveness checks / tracking where applicable. Follows up based on effectiveness check results.
• Performs data trending and prepares periodic reports related to complaints and quality issues and supports post-market surveillance activities
• Coordinates Product Quality Committee meeting to determine appropriate plans for actions to be taken
• Will serve as a subject matter expert and assist with mentoring and training new hires
• Responsible for running assays to confirm / investigate customer complaints, supporting QA validation studies, and writing test reports
• Provides track and trending for potential health and safety complaints
• Provides feedback to Mfg / R&D to improve quality : Leads cross-functional teams from internal departments / outside vendors to establish appropriate processes for product quality improvements
• Training : Completes training in a timely manner. Maintains training records. Organizes internal cross training / external training sessions.
• Presents results and communicates results within / outside of the group
• Coordinates regional meetings with field service engineers and field service reps
• Maintains laboratory equipment in a calibrated state and completes necessary documentation
• Responsible for taking regular inventory and ordering lab supplies
• Assist in Audit preparation as needed and prepare reports per auditory / regulatory needs. May be trained as an internal auditor. Address any issues related to the investigation process with the auditor as needed.

Knowledge, Skills, and Abilities

Requires a bachelor's degree

Minimum of 8 years of relatable experience. Work experience in complaint handling and investigation in a regulated setting is required. Experience in technical writing and trend analysis is preferred.

Depending on the area of assignment, directly related experience or a combination of directly related education and experience and / or competencies may be considered in place of the stated requirements. Example : If a job level requires a Bachelor's degree plus 4 years of experience, an equivalency could include 8 years of experience, an Associate's degree with 6 years of experience, or a Master's degree with 2 years of experience.

Occupational Demands Form # 9 : Work is performed in an office environment with exposure to electrical office equipment. Frequently sits for 6-8 hours per day. Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists. Frequently walks. Occasionally bends and twists neck. Light to moderate lifting and carrying objects with a maximum lift of 30lbs. Frequently drives to site locations with occasional travel within the United States. Able to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences. Interacts with others, relates sensitive information to diverse groups.

The estimated pay scale for the QA Complaint Specialist III role based in San Diego, CA, is $119,397.60 to $149,247.00 per year. Additionally, the position is eligible to participate in up to 8% of the company bonus pool. We offer a wide variety of benefits including, but not limited to : Medical, Dental, Vision, PTO, up to 5% 401(K) match and tuition reimbursement. Final compensation packages will ultimately depend on education, experience, skillset, knowledge, where the role is performed, internal equity and market data. We are committed to offering our employees opportunities for professional growth and career progression.

Grifols provides equal employment opportunities to applicants and employees without regard to race; color; sex; gender identity; sexual orientation; religious practices and observances; national origin; pregnancy, childbirth, or related medical conditions; status as a protected veteran or spouse / family member of a protected veteran; or disability. We will consider for employment all qualified applicants in a manner consistent with the requirements of all applicable laws, including but not limited to, the California Fair Chance Act, the Los Angeles County Fair Chance Ordinance for Employers, and the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.