Assures compliance and progress toward company established goals of the organization as the quality department head and designated management representative through developing and enforcing quality management systems and procedures; good business practices; understanding, communicating and assuring customer expectations; building in quality to assure consistent quality products in a timely manner; validating and auditing processes; documentation control; managing staff. |
Major Duties & Activities Required by the Position:
Education and/or Experience:
- Accomplishes business assurance objectives and effective operation of the compliance organization by understanding, communicating, training and enforcing compliance standards, policies and procedures including but not limited to regulatory affairs, medical device regulations and standards, and environmental health and safety. Responsible for planning, organizing, and directing all compliance activities.
- Assures compliance with all internal and external requirements and regulations through the maintenance and improvement of the quality management system. Develops and issues status reports to monitor the effectiveness of the QMS at Orchid Santa Ana.
- Achieves quality assurance operational objectives by serving as the appointed management representative and developing and monitoring appropriate site specific quality metrics to enhance compliance requirements and meet company objectives. Follows-up on corporate quality KPIs and ensures appropriate measures are taken to reach set KPIs.
- Contributes information and analysis to strategic plans and reviews; preparing and completing action plans; implementing appropriate countermeasures for KPI’s, identifying and resolving problems; completing audits; determining system improvements; implementing change.
- Adds customer value through developing procedures and providing leadership to cross functional teams, formal problem solving (including true root cause analysis), PDCA, statistical analysis to reduce variation, built in quality, etc.
- Meets quality assurance financial objectives by estimating requirements; preparing an annual budget; scheduling expenditures; analysing variances; initiating countermeasures.
- Ensure all Quality System documentation is processed and archived appropriately. (Quality System documents include, but are not limited to, manuals, procedures, instructions, forms and the applicable standards).
- Develops quality assurance (APQP) plans to understand and mitigate risk to our customers by working directly with them and identifying critical control points and preventive measures; establishing critical limits, monitoring procedures, corrective actions, and verification procedures; monitoring effectiveness. Ensure this proactive understanding of customer expectations/concerns is communicated to bring quality to the source which include, but not limited to, metrology, cosmetics, inspection technique and method, paperwork/certifications, and quality scorecards relating to performance.
- Manages the corrective and preventive action (CAPA) system and ensures timely and adequate action is taken. Ensures timely analysis and reporting of all customer and internal complaints.
- Validates quality processes by establishing product specifications and quality attributes; measuring production; documenting evidence; determining operational and performance qualification; writing and updating quality assurance procedures.
- Maintains and improves product quality by completing product, company, system, compliance, and surveillance audits; reporting complaint trends; collaborating with other members of management to develop new product and engineering designs, and manufacturing and training methods. Directs internal and external audits of the quality system and is responsible for all follow-up activities and timely responses.
- Prepares quality documentation and reports by collecting, analyzing and summarizing information and trends including failed processes, stability studies, recalls, corrective actions, and re-validations. Interfaces with Quality and Regulatory personnel throughout the corporation.
- Provides quality system training to all new employees and conducts ongoing refresher training for existing employees.
- Updates job knowledge by studying trends in and developments in quality management; participating in educational opportunities; reading professional publications; maintaining personal networks; participating in professional organizations.
- Enhances department and organization reputation by accepting ownership for accomplishing new and different requests; exploring opportunities to add value to job accomplishments.
- Maintain an “open and confidential” communication system that promotes a union-free workplace.
- Ensure timely and accurate record keeping of the attendance policy and labor reporting to meet the goals of the company.
- Assist Human Resources in the selection process of appropriate personnel for departmental needs.
- Assign appropriate personnel to production operations as required.
- Effectively communicate performance goals and expectations with employees to help in their continuous improvement.
- Communicate regularly with Technical and Production Managers on quality, schedules, work flow and operations.
- Communicate changes of personnel/payroll status/shift change to Human Resources.
- Perform other related work assignments as directed by the Technical Manager or Director of operations.
- Promote a proactive, cooperative attitude towards issues of environment, health, and safety.
Preferred Qualifications Include:
- Bachelor’s degree in related discipline and/or 10 years work experience including: Five or more years of relevant quality system experience in a highly regulated industry such as medical devices, aerospace, automobile or nuclear, experience with ISO/CE certification process and experience with US and relevant international medical device regulations. Masters degree preferred.
- Knowledge of ISO13485/14971, Medical Device regulations (i.e. FDA 21CFR820), problem solving, APQP (Process Flow/PFMEA/Control Plans/FAI’s), statistical process control.
- Must have a minimum of 2 years supervisory experience, preferably in the medical field; or equivalent combination of education and experience.
- Quality certifications (e.g., ASQ CQE, CRE, CQM, etc.).
- Skills & Abilities:
- Strong computer and interpersonal communication skills
- Ability to prioritize and manage multiple tasks with varying and short timelines
- Strong interpersonal skills
- Good verbal communication skills
- Ability to interact with all levels of employees and customers
- Ability to successfully manage multiple projects and daily responsibilities
- Ability to discern and appropriately communicate sensitive issues
- The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- While performing the duties of this job, the employee is regularly required to sit and talk or hear. The employee frequently is required to stand; walk; and use hands to finger, handle, or feel objects, tools, or controls. The employee is occasionally required to reach with hands and arms. The employee must occasionally lift and/or move up to 15 pounds. Specific vision abilities required by this job involve normal vision.
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