Senior QA Complaint Specialist

Location: 

CA-San Diego, US

Contract Type:  Regular Full-Time
Area:  Quality
Req Id:  497795

Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.

Summary:

The Senior QA Complaint Specialist independently conducts investigation into NAT assay related complaints, performs data trending and prepares periodic reports, reviews/updates/creates SOPs, supports the reporting decision process of MDR/BPDR, leads CAPA teams, prepares reports per auditory/regulatory needs, addresses issues during audits, and performs work related to their area of expertise (including but not limited to supporting MDR reporting and Audit, coordinating PQC and improving investigation process).  This role also leads cross-functional teams from internal departments/outside vendors to establish appropriate processes for product quality improvements. Coordinates regional calls.  Mentors junior level team members.                                                                                        

                                                           

 Primary responsibilities for role:

Investigation: Independently conducts complex complaint investigation 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.                    

Coordinates obtaining detailed information and return of affected material to support complaint investigation                    

Conducts review QC data and Non-conformance reports                    

Drafts investigation reports to support final closure of complaints and submits for review and approval                    

Performs data trending and prepares periodic reports related to complaints and quality issues                    

Assist in mentoring junior members in investigations                    

Reviews/updates/creates SOPs to standardize and improve the investigation process.                    

Potential Health and Safety Complaints Evaluation/Reporting: Applies knowledge of medical device regulatory requirements to support the reporting decision process and identify reportable events within short timeframes                    

Coordinates Product Quality Committee meeting to determine appropriate plans for actions to be taken                    

Provides track and trending for Potential Health and Safety Complaints                    

Device History Records Review: Conducts review of DHR documentation including but not limited to batch records                    

CAPA: Leads CAPA actions, including managing cross-functional CAPA teams, planning, drafting/approving protocol and design experiments, execution, & effectiveness checks/tracking where applicable. Follows up based on effectiveness check results.                    

Provide 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                    

Ensures implementation/sustainability and monitors the field quality of the improvements                    

Regional calls: Coordinates regional meetings with field service engineers and field service reps                    

Audits: Assist in Audit preparation as needed and prepares reports per auditory/regulatory needs. Address any issues related to the investigation process with the auditor as needed.                    

May lead a small team of a team of direct reports. Evaluates and coaches direct reports; makes recommendations regarding personnel changes including but not limited to development and performance management                    

Training: Completes training in a timely manner. Maintains training records. Organizes internal cross training/external training sessions. Review/update/create training for SOPs.                    

May participate in process improvement teams and lead projects                              

 

 

                                                                                               

 

Education:

Minimum: Bachelor's degree with 10 years of relatable experience in biology, chemistry, biochemistry or biomedical engineering field

 

 

Experience:

Minimum of 10 years of relatable experience with Bachelor's degree. Work experience in complex complaint handling and investigation, advanced SOP and post market surveillance report writing, leading projects or core teams and managing a small group is highly preferred.                                                                                            

 

 Occupational Demands:

  • May occasionally lift, carry, push, pull or otherwise manipulate objects up to 25 pounds in weight, and/or lift, carry, push, pull or otherwise manipulate objects up to 10 pounds in weight frequently or continuously.

 

Pay Scale:

Pay scale of $113,000-141,000/year, depending on training, education, and experience.  This position is eligible to participate in up to 8% of the company bonus pool.  We offer benefits including medical, PTO, up to 5% 401K match, and tuition reimbursement. We are committed to offering our employees opportunities for professional growth and career progression. Even though we are a global healthcare company with employees in 30 countries, Grifols prides itself on its family-like culture. Our company has more than tripled its workforce in the last 10 years — we’re growing, and you can grow with us!       

 

 

EEO Minorities/ Disability/Veterans

Grifols is committed to Equal Employment Opportunity (EEO) and to compliance with all Federal, State and local laws that prohibit employment discrimination on the basis of race, color, age, national origin, ethnicity, religion, gender, gender identity, pregnancy, marital status, sexual orientation, citizenship, genetic disposition or characteristics, disability or veteran's status or any other classification protected by applicable State/Federal laws.  We will consider for employment all qualified Applicants, including those with Criminal Histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance.

 

Location: NORTH AMERICA : USA : CA-San Diego:USSDW - San Diego CA - Willow Ct Mfg 

 

Learn more about Grifols

 


Nearest Major Market: San Diego