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Senior Manager of Quality Compliance

Company: SeaSpine
Location: Carlsbad
Posted on: March 20, 2023

Job Description:

If you are a job seeker with a disability and require a reasonable accommodation to apply for one of our jobs, you will find the contact information to request the appropriate accommodation by visiting the following page:We are a leading global spine and orthopedics company with a premier portfolio of biologics, innovative spinal hardware, bone growth therapies, specialized orthopedic solutions and a leading surgical navigation system. Our combined company is over 1,600 strong, with products distributed in 68 countries worldwide and a global R&D, commercial and manufacturing footprint, and this is just the beginning!Come join our global team of dedicated professionals who through their extraordinary efforts demonstrate every day their commitment to our mission of improving the lives of patients. At SeaSpine and Orthofix our culture is built around Integrity and the core beliefs we live by: Exceed Expectations, Work Together, Be Respectful, Get Lean and Have Fun!How you'll make a difference:This position is responsible for developing, defining, educating, advocating, and managing a superior compliance culture throughout the company. Likewise, this position must ensure QS compliance with company quality system requirements as well as applicable standards and regulations. This position is responsible for ensuring the company's management and employees are in compliance with the rules and regulations of regulatory agencies and that company policies and standard operating procedures are being followed.Your key responsibilities: -

  • -Ensures appropriate quality management system requirements have been effectively established and implemented to maintain compliance with US FDA's Quality System Regulation, the European Medical Device Directive / Regulation, ISO13485, American Association of Tissue Banks (AATB), and other relevant domestic and/or international regulatory requirements. -
  • Executes Gap Analysis and/or Risk Assessments to ensure evaluation of key areas, such as manufacturing operations, laboratory and maintenance and engineering, are in compliance with all regulatory requirements, e.g., cGMPs, FDA Guidelines, USP, etc.
  • Monitors completion of Post-Market activities, including complaint handling, adverse event reporting, Health Hazard Evaluations (HHE), and Post Market Surveillance to verify satisfaction of regulatory requirements, and manages or supports Recalls and Field Removals. -
  • Maintains awareness of regulatory landscape and takes appropriate steps to ensure continued QMS compliance.
  • Ensures the Quality Policy and Manual have been effectively established, communicated, and implemented to maintain compliance with domestic and/or international regulatory requirements.
  • Maintains CAPA process and verifies CAPA's are implemented as required to maintain suitability of both products and the Quality System
  • May provide training and/or training presentation documentation pertaining to FDA inspections, e.g. FDA hot topics, interaction with FDA officials, new regulatory approaches to inspections, etc.
  • Ensures Quality Management System audits are planned, performed, results reported to executive management, and necessary / required corrective and/or preventive actions are taken in accordance with established procedures.
  • Monitor risk management process, including post-production risk, to ensure all regulatory and compliance obligations are satisfied.Who you are:
    • Bachelor's degree in engineering preferred or equivalent
    • 10 years' experience in medical device industry and quality systems, quality auditing, and/or regulatory compliance experience.
    • 4 years' Management experience.
    • Knowledge of domestic and international medical device quality system laws, regulations, and standards, such as 21CFR Part 803/806/820, 21CFR Part 1271, ISO 13485:2016, ISO 14971.
    • Excellent technical writing skill and ability to communicate well (both written and verbal) laterally and vertically.
    • Project planning and management capability a must.
    • Logical cognitive skills and ability to apply scientific methods and/or systems thinking.
    • Ability to identify variables affecting all aspects of quality.
    • Ability to meet deadlines and/or objectives as directed.
    • Must be able to interpret device law into workable, efficient, and effective practices and procedures.
    • Lead auditor certification highly desired
    • Knowledge of internet investigation for new and updated standards - preferred -
    • Experience with global audits such as with Brazil and Japan- preferred -
    • Current with domestic regulatory thinking - preferred -
    • Experience in the spine and/or orthopedic industry - preferred -
    • Experience with medical device reporting and complaint management a strong plus - -preferred
    • Knowledge of statistical techniques - -preferred -Salaried Employees: The anticipated salary for this position is $154,865 to $171,072 per year, plus bonus, equity, and benefits. The final pay offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and years of experience within the job, the type and years of experience within the industry, education, etc.We are committed to providing equal employment opportunities to all employees and applicants without regard to race (including traits historically associated with race, such as hair texture and protective hairstyles, including braids, locks, and twists), ethnicity, religion, color, sex (including childbirth, breast feeding, and related medical conditions), gender, gender identity or expression, sexual orientation, national origin, ancestry, citizenship status, uniform service member and veteran status, marital status, pregnancy, age, protected medical condition, genetic information, disability, or any other protected status in accordance with all applicable federal, state, and local laws.This policy extends to all aspects of our employment practices including, but not limited to, recruiting, hiring, discipline, termination, promotions, transfers, compensation, benefits, training, leaves of absence, and other terms and conditions of employment.

Keywords: SeaSpine, San Diego , Senior Manager of Quality Compliance, Accounting, Auditing , Carlsbad, California

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