Senior Quality Engineer QA Complaints

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.

The Senior Quality Engineer QA Complaints Independently writes complex investigations for Hardware, Software, and System level complaints, performs data trending and prepares periodic reports, reviews/updates/creates SOPs, supports the reporting decision process of MDR/BPDR and other Adverse Events, leads CAPA actions, prepares reports per auditory/regulatory needs, addresses issues during audits as an SME, and performs work related to their area of expertise in Hardware, Software, and System level complaints and projects (including but not limited to supporting MDR/Adverse Events 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. 

Primary responsibilities for role: 

• Investigation: Independently write complex investigations for Hardware, Software, and System level complaints through interfacing with Field Service, R&D, and 3rd party vendors to acknowledge, document, analyze information and data, perform and review deeper investigation into root causes, and assign additional actions as necessary to close the complaint.
• Coordinates with customers and field service engineers in obtaining detailed information like system log file and other instrument data and return of affected material to support complaint investigations
• Conducts review of relevant QC data and Non-conformance reports as required to investigate Hardware, Software and System complaints.
• Compiles all information and drafts final 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
• Assists R&D in conducting troubleshooting to resolve Hardware, Software, and System complaints as needed.
• Reviews/updates/creates SOPs to standardize and improve the investigation process.
• Coordinate with Supplier Quality to issue vendor notifications (SCAR) in order to address Hardware, Software, and System level complaints related to 3rd party vendors.
• 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 allowed timeframes for Hardware, Software, and System complaints
• Coordinates Product Quality Committee meeting for Hardware, Software, and System complaints to determine appropriate plans for actions to be taken
• Provides track and trending for Potential Health and Safety for Hardware, Software, and System Complaints. Leads risk assessments/ design FMEA updates as required.
• Device History Records Review: Conducts review of DHR documentation including but not limited to batch records as related to resolution of Hardware, Software, and System Complaints
• CAPA: Leads CAPA actions and effectiveness checks originating from root casue analysis of Hardware, Software, and System complaints. Tracks Software and Hardware mitigations to ensure effectiveness of corrective actions.
• 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.
• Regional calls: Coordinates regional meetings with field service engineers and field service reps
• Audits: Participate in audits as a Subject Matter Expert for Hardware, Software, and System complaints as and prepares reports per auditory/regulatory needs. Address any issues related to the investigation process with the auditor as needed.
• 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

Knowledge, Skills, and Abilities  

• Excellent writing skills, including independently writing investigation reports, reports per auditory/regulatory needs (incl. Post market surveillance report), SOPs, and review of the reports.
• Excellent presentation skills, including independently preparing and presenting investigation findings, organizing presentations and presenting data
• Advanced SAP/salesforce experience including data collection and analysis a plus.
• Advanced skills in Excel (data trending analysis), Word, Power Point, Statistical software. Proficiency in data analysis tools including pivot table and other softwares.
• Knowledge of GMPs.
• Team oriented and willing to work collaboratively and learn new skills
• Strong organizational skills and attention to detail
• Demonstrates technical knowledge and sound decision making
• Expert in proactively identifying trends, reporting to management, problem solving, and presenting solutions
• Handles multiple projects and prioritizes accordingly to meet competing deadlines
• Excellent communication skills and ability to work with a cross-functional team
• Project management and organizational skills.                            

Education        

Minimum: Bachelor's degree with a minimum of 8 years of relatable experience in Software, Hardware, System level complaints in a  biomedical engineering field                                                           

Experience

Minimum of 8 years of relatable experience with Bachelor's degree.                                                         

Equivalency

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 10 years of experience, an equivalency could include 14 years of experience, an Associate’s degree with 12 years of experience, or a Master’s degree with 8 years of experience.

Occupational Demands 

May occasionally lift, carry, push, pull or otherwise manipulate objects up to 10 pounds in weight, and/or lift, carry, push, pull or otherwise manipulate objects of a negligible weight frequently or continuously. Sedentary work involves sitting the majority of time for 6-8 hrs. Use of hands for typing. Job is sedentary as walking and standing are required only occasionally.            

Pay Scale

The estimated pay scale for the Senior Quality Engineer QA Complaints role based in San Diego, CA, is $131,252.95 to $164,065.90 per year. Additionally, the position is eligible to participate in up to 15% 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 is a global healthcare organization with employees in 30 countries focused on patient health and providing impactful results. Since our humble beginnings in 1909, Grifols has been a family company that prides itself on its family-like culture. Our company has more than tripled over the last 10 years, and you can grow with us!                                              

Third Party Agency and Recruiter Notice:

Agencies that present a candidate to Grifols must have an active, nonexpired, Grifols Agency Master Services Agreement with the Grifols Talent Acquisition Department. Additionally, agencies may only submit candidates to positions that they have been engaged to work on by a Grifols Recruiter. All resumes must be sent to a Grifols Recruiter under these terms or they will be considered a Grifols candidate.

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.

California Personnel Privacy Policy and Notice at Collection

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

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