A quality engineer is a professional who plans, develops, monitors, tests, maintains, and improves as required, the
quality of products and/or processes in industries such as manufacturing and/or services, ensuring compliance with
customer requirements, applicable standards and applicable regulations (21 cfr part 820, en iso 13485, others
applicable), identifying opportunities for improvements, recommending solutions as result of a proper investigation and definition of the root cause, and implementing required corrective and preventive actions to avoid occurrence and reoccurrence of identified opportunities. All described activities working along with manufacturing and any other company departments as required.
understand the term manufacturing as operations. Centerpiece s. de r.l. de c.v. (manufacturing and sterilization sites) applies as manufacturer based on 21 cfr part 820 subpart a-general provisions section 820.3 definitions (o)
manufacturer.
essential duties and responsibilities:
* provide leadership to the quality inspection team, driving a culture of quality, compliance, and continuous improvement across the organization.
* develop and implement plans for the quality inspection team function, ensuring organizational goals are met while adhering to regulatory and safety standards.
* participate in regular meetings with cross-functional teams (engineering, manufacturing, regulatory, operations, others) and as required, with customers, specific to quality compliance topics.
* support to establish and maintain a robust qms in compliance with iso 13485, fda 21 cfr part 820 and other relevant regulation applicable to the company driving its continuous improvement where applicable to ensure effectiveness, efficiency, and alignment with company and customer expectations.
* oversee and/or work on the implementation of corrective and preventive actions (capas) to address quality issues and minimize product risks as well as ensure full compliance with the corrective and preventive action (capa) system, verifying plan implementation and reporting on capa statistics.
* any responsibility agreed in any qms documented processes.
* ensure all products meet regulatory requirements by meeting specifications.
* ensure that all established processes are properly followed in compliance with regulations.
* support on external third-party quality system inspections and audits (fda, notified bodies, international regulatory agencies, etc.).
* oversee risk management activities in product development and manufacturing, ensuring risk assessments
* and mitigations are conducted.
* ensure that actions, improvements and any decision is made, are based on risks.
* ensure that any potential risk associated to processes or product, gets properly handle and inform to supervision and management.
* ensure all materials, components, and finished goods meet quality and regulatory standards.
* communication with supplier as required, to improve quality and/or regulatory concerns.
* review any supplier investigation related to quality concerns impacting manufacturing process.
* ensure training of quality inspectors on quality systems, product and tests requirements, and best practices.
* mentor and develop a high-performing quality assurance team, fostering a collaborative, high-integrity, and results-driven environment.
* maintains professional and technical knowledge by attending educational workshops, reviewing professional publications, establishing personal networks and benchmarking state-of-the-art practices.
* track quality performance, identify trends, and drive improvements.
* maintains statistical process controls by applying demerit/unit, zone charting, x2 charts for distributions, p-charts, tendency charts, etc., as applicable and as suitable to company processes.
* report quality metrics to supervisor and/or management as required. executive leadership, providing insights and recommendations to improve quality outcomes and operational performance.
* ensure the compliance to quality objectives (e.g., customer satisfaction, regulatory standards) and the effectiveness of corrective measures.
* determines quality improvement parameters by identifying statistical methods relevant to manufacturing processes as applicable.
* propose improvement to established processes to avoid quality and/or regulatory concerns.
* support field actions and product recalls by managing customer notifications, product documentation, and follow-up activities to ensure closure. ·
* develops sampling plans by applying attribute, variable, and sequential sampling methods as applicable.
* establishes statistical confidence by identifying sample size and acceptable error and determining levels of confidence as applicable.
* develops general control plans by customer, product and/or product families. o analyzes data by completing any of the tools to analyze data: hypothesis, normal distribution, process capability analysis tests, etc…, as applicable.
* prepares reports by collecting, analyzing, and summarizing data; and making recommendations.
* review, improve and approve as needed, qualifications and validations as required.
* validate and authorize standard operating procedures (sops) to ensure compliance and consistency. · interdepartmental coordination:
* promote and maintain interdepartmental harmony, ensuring smooth collaboration across various functions and departments.
* contributes to team effort by accomplishing related results as required.
* performs all other duties and responsibilities that are reasonably assigned from time to time by the employer or its designated representative as needed.
* brainstorms ideas to create solutions for identified problems.
* collaborate with cross-functional teams (engineering, manufacturing, regulatory, operations, others) to align quality initiatives and ensure customer process and product requirements.
details of the skills, knowledge and experience required for the position.
academic background:
* bachelor's degree in engineering, life sciences, or a related field (master's degree preferred).
work experience:
* 2+ years of experience in quality assurance within the medical device industry, with at least 1 year in charge of people.
* knowledge of medical device regulatory requirements (fda and iso
* experience with risk management processes.
* proven track record of leading root cause analysis.
technical skills:
* commitment to the product quality and the quality system of centerpiece s. de r.l. de c.v..
* familiarity with and adherence to all applicable regulations at the federal, local, and state levels.
* demonstrated ability to successfully manage multiple projects simultaneously.
* knowledge of computer software: sap, microsoft, minitab and eqms as minimum.
* proficiency in quality tools such as capa, ncr, fmea, and risk assessments.
soft skills:
* leadership, communication, and interpersonal skills, with the ability to influence and collaborate across functional areas.
* professional presence with comfort in interacting with associates at all levels of an organization, both internally and externally, including executive leadership.
* actively fosters and contributes to a positive teamwork environment.
languages:
* advanced english, both written and spoken (essential).
tipo de puesto: tiempo completo
sueldo: $ $1,700.00 al día
beneficios:
* descuentos y precios preferenciales
* opción a contrato indefinido
* seguro de gastos médicos mayores
* vales de despensa
puede trasladarse/mudarse:
* 22706, rosarito, b.c.: trasladarse al trabajo sin problemas o planear mudarse antes de comenzar a trabajar (obligatorio)
experiencia:
* in quality assurance within the medical device industry: 2 años (obligatorio)
* medical device regulatory requirements (fda and iso : 1 año (obligatorio)
* risk management processes.: 1 año (deseable)
idioma:
* inglés (obligatorio)
lugar de trabajo: empleo presencial