Sr. Quality Assurance/Quality Control Specialist

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Bayside Solutions
medical device, quality control, quality assurance
Full Time, Permanent
EU80000 per annum

Job Description

The Sr. Quality Assurance / Quality Control Specialist is a central role in the ICON medical device team in Pleasanton, CA. This is a hybrid QA/QC role. We are looking for a closure-oriented QA specialist that wants to include QC responsibilities in their daily routine to maintain a close connection to production, or a detail-oriented QC specialist that is interested in expanding their role to the implementation and operation of the QMS.

Essential Job Duties and Responsibilities:

Essential responsibilities and duties include, but are not limited to, the following:

  • Administer digital QMS processes including Document/Change Control, CAPA, Complaint, NCR, and Internal Audit programs.
  • Enter Complaints and prepare materials for the monthly Complaint Review Board
  • Compile and review key QMS indicators and performance data of quality systems to assess their continued suitability, adequacy, effectiveness, and efficiency, and issue periodic reports to management.
  • Perform final quality control inspection of ICON products to ensure medical device conformance prior to release to finished goods.
  • Perform incoming quality inspections of ICON related parts following established inspection procedures to ensure received material conforms to specification.
  • Communicate quality information to all relevant departments, outside vendors, or contractors in support of the QA/RA and manufacturing teams.
  • Support the Director of RA/QA to ensure all quality standards and regulatory requirements are met, and compliance is maintained, with all local, state, federal, and applicable international regulations.
  • Additional duties as required.
Job Qualifications and Education:

  • Bachelor of Science degree or equivalent in molecular biology, chemistry, life sciences or medical device engineering.
  • Minimum of 4 years of experience in a QA/QC role.
  • Strong working knowledge of quality systems, Good Manufacturing Practices (GMP), and ISO standards (9001 or 13485) with start-up experience preferred.
  • Understanding of risk management principles and ability to apply these principles in day-to-day quality management activities, quality and compliance issues, and business challenges.
  • Critical thinker with the ability to read, analyze, and interpret technical data.
  • Ability to lead, train, motivate, and work effectively within a team.
  • Excellent spoken and written interpersonal communication skills including the abilty to work effectively with a distributed team.
  • Good conceptual, analytical, problem solving, planning, and organization skills, including demonstrated prior accomplishments.
  • Ability to multi-task and wear multiple hats, assisting departments as needed.
  • Ability to prioritize and adapt to changing priorities while maintaining a high-quality standard.
  • Proficient in Microsoft Office (especially Word, Excel, and PowerPoint).
  • Experience with Arena QMS preferred

Other duties as assigned by management.

Knowledge, Abilities, and Skills:

  • Candidate must have minimum 4 years medical device industry experience.
  • Candidate likely has a strong QC background and has performed quality testing and inspection.
  • Candidate must have working knowledge of Arena or other digital Quality Management Systems. (Agile, Arena, Greenlight Guru, etc.)
  • Strong knowledge and competence in 1) application of FDA-Quality System Regulation (21CFR820) 2) medical device complaint handling and MDR/Vigilance reporting requirements, and 3) ISO 13485 quality system management requirements.
  • Knowledge of Federal Food, Drug and Cosmetic Act; Code of Federal Regulations; FDA guidelines.

Company Information

Bayside Solutions is an industry-leading provider of staff augmentation and consulting services.

Bayside Solutions is built around a single concept – relationships. We focus on the people we serve. We’re straightforward, consistent and 100% accountable. We deliver more intelligent solutions that help our clients and candidates thrive.

Our relationship-driven network and philosophies allow us to be flexible, identifying and fixing our clients’ unique problems-- providing the key people they need, adding value to their businesses, and delivering surprising levels of service.

Specializing in a handful of verticals and industries, we design flexible solutions that effectively address our clients’ and contractors’ needs, initiatives and goals. Our service philosophy is based on our TACIT Values: Trust/Accountability/Consistency/Integrity/Teamwork – the inherent principles that guide everything we do.

We can offer the sorts of solutions that make your business more efficient, allowing you to capitalize on opportunities and send your bottom line soaring. We know the top professionals in your industry, their strengths, their goals and their objectives. And best of all, we can deploy top people when you need them, where you need them.

Bottom line, we’ve raised the bar in workforce solutions. Better talent. Better ideas. Better value.

We’re Bayside Solutions. What can we do for you?

Dice Id : 10119262
Position Id : 100976732140047
Originally Posted : 4 months ago

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