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25 days old

Product Compliance Specialist II/III (Santa Ana, CA)

Kelly Services
Santa Ana, CA 92702
**Product Compliance Specialist II/III**

**Santa Ana, CA**

**Direct-Hire, Full-Benefits**

**Pay: Depends on Experience**

**Mon-Fri 1st Shift, Hybrid (2 days on, 3 days off)**


**Job Summary:**

The Product Compliance Specialist independently support and assist execution of Quality System product compliance tasks related to Complaints, CAPA, Quality Planning, and Facility Change Requests (FCRs). This is a full-time, direct-hire role located in Santa Ana, CA with a hybrid 2 days on-site/3 days remote from home work schedule.


**Essential Duties:**


+ Lead Compliance activities, including, but not limited to, the following:

+ CAPA initiation, investigation support of assigned CAPA owners, and CAPA closure

+ Review and planning for Facility Change Requests (FCR)

+ Write, review and closure of Quality Planning Activities among all sites

+ Complaint documentation intake, investigation oversight, customer follow-up, tracking and trending

+ Determine the nature of direct and indirect customer inquiries, and classify them for resolution.

+ Managing of individual complaints, and monitoring customer inquiries associated with complaints or CAPAs. Coordinating cross-functional activities for Compliance responsibilities.

+ Ensuring timely and accurate closure of customer complaints, CAPAs, FCRs and Quality Planning activities and that established turnaround times are met.

+ Ensuring compliance of processes and procedures to applicable standards related to Compliance activities, including but not limited to, complaints, CAPAs, FCRs and Quality Planning.

+ Assisting in the communication with regulatory agencies, notified body, and competent authorities as associated with Compliance activities.

+ Support activities relating to customer and regulatory audits.

+ Complete Medical Device Reporting decision forms

+ Perform Risk Assessments for FCR, CAPA, and Complaint Investigations as required

+ Independently lead product complaint investigations, implementing corrective actions as necessary


**Job Requirements:**


+ B.S. or B.A. in scientific discipline preferred.

+ 2-6 or more years of experience in Quality Assurance/Regulatory Affairs/Compliance, technical and customer support in a medical device discipline.

+ GMPs, CFRs, USP, ISO 13485, CMDR, MDD 93/42/EEC, IVD D 98/79/EC, ISO harmonized standards (EN14971, EN 13408, EN 13824).

+ Quality control methodology, QA control systems and production methodologies.

+ Experience in cell and tissues culture. Experience can be from education or industry.

+ Ability to obtain cooperation from other groups and lead cross functional teams.

+ Experience with risk management and Failure Mode Effects Analysis (FMEA).

+ Strong root cause analysis skills required.

+ Ability to speak, read and write English proficiently.

+ Good oral and written communication skills

+ Proficient in Microsoft Word, Excel, PowerPoint, Outlook.




**You should know:** Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.


**Why Kelly** **** **Science & Clinical?**


Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the worlds most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goalsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.


**About Kelly** ****


At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kellys Human Resource Knowledge Center.
Kelly complies with the requirements of Californias state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.

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Posted: 2022-09-12 Expires: 2022-10-13

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Product Compliance Specialist II/III (Santa Ana, CA)

Kelly Services
Santa Ana, CA 92702

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