We are currently searching for a skilled professional to join a well-known client's team as a Senior Post-Market Quality Engineer in Santa Clara, California. This role will manage post-market activities, including complaint handling, the eMDR process, CAPA's, internal/external audits, and analysis of trending post-market data. If you are a career-focused professional, this is the role for you.
RESPONSIBILITIES
Perform product investigations for the complaints received including the diagnosis, failure analysis, root cause determination, and the completion of the complaint investigation report
Oversee the Complaint Management process by providing direction for the Complaint Team and technical support
Coordinate the actions of the Complaint Review Committee (CRC) to ensure that adverse events involving the products are adequately investigated and filed on time with the regulatory authorities
Initiate, investigate, or coordinate CAPA's involving the products and/or internal processes where noncompliance with procedures, regulatory requirements, and industry standards governing the products are discovered
Provide input for the Risk Management process to assure that the risk profiles of the products are compliantly maintained as assessed against the post-market surveillance data
Conduct trend analysis and provide data for the Management Reviews and CAPA Counsel meetings using post-market surveillance data
Support internal and external audits as a member of the QA audit team
Collaborate cross-functionally on the complaint and CAPA investigations and work to enhance the procedures or processes where inefficiencies are found
EXPERIENCE
Minimum of 4 years of experience in medical device quality assurance with direct hands-on product investigation skills diagnosing and analyzing product complaints for their root cause and developing product complaint trends, writing and closing complaint investigation reports, and maintaining the CAPA, NCR, and internal/external audit programs required
Strong documentation, investigation, and data collection skills required
Experience with the FDA quality system regulations (QSR's) and ISO 13485 required
Good communication skills and ability to learn by being challenged
Knowledge of the FDA QSR's (21 CFR 820) and ISO 13485, ISO 14971
Experience with the Canadian Medical Device Regulations desired
Leadership and management experience with small teams or mentoring junior engineers desired
EDUCATION
Minimum of Bachelor's Degree in Engineering or a technical discipline required
To be a best-fit your strengths must include:
Strong Communicator. You will have extensive correspondence that relies on you being conversant in regulatory guidelines and clinical terminology.
Organized. You're an efficient time-manager and can handle the pressure of meeting multiple strict deadlines.
Ability to work independently and with a team: You will be collaborating and often contributing to discussions amongst internal teams; you also work effectively without a lot of support or structure.
Problem-Solvers. As an action-oriented self-starter, you're eager to apply your expertise in diagnosing inefficiencies, determining root causes, and recommending solutions to complex challenges.
Personable. You establish and nurture highly effective relationships with colleagues and key stakeholders that support and advance project goals and objectives.
Credible. Thorough understanding of clinical methodologies and providing sound analytical support, you quickly establish credibility as a reliable resource.
About Advanced Clinical
Advanced Clinical is an award-winning clinical development organization that provides global services including CRO, Functional Support, Quality & Validation, Patient Recruitment and Retention, and Strategic Talent Acquisition solutions for pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations. Our mission is to deliver a truly better clinical experience for our clients and candidates. To learn more about Advanced Clinical which has been named to Chicago Tribune's Top Workplaces, Chicago's Best and Brightest Companies, and Best of Staffing Talent & Client, visit http://www.advancedclinical.com.
Regarding your application
Please know that every completed application is carefully reviewed by the Advanced Clinical recruitment team. We understand the time commitment that is needed to prepare an application, so we respect your effort by thoughtfully reviewing and responding to each application. In return, we ask for your patience as careful review takes time, and we may not be able to respond to every application immediately.
It is Advanced Group's practice not to discriminate against any employee or applicant because of sex, race, color, age, national origin, religion, gender, gender identity/expression, sexual orientation/sexual preference, pregnancy/maternity, genetic information, marital status, physical/mental disability, medical condition, military/veteran status, or any other basis protected by applicable federal, state, or local law. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter so that we can discuss the appropriate alternatives available.
