Quality Director (ISO 13485)
- for any list of duties/requirements/benefits. Use
for prose. We need to preserve all substantive information; do not invent or summarize away detail. So we need to include all bullet points from responsibilities etc. But we need to format as lists. We have a long paragraph of responsibilities. We can break into bullet list items for each duty. The text includes many sentences separated by periods. We'll need to extract each duty as a list item. Must preserve all info; not lose any. We'll need to parse the given text. Let's extract responsibilities section: Starting after "Essential Job Functions and Responsibilities:" then list. Text: "Responsible for , leading developing, implementing and manage an effective quality management systems that supports the company-wide quality policy, ISO 9000, ISO 13485 and FDA 21 CFR 820 regulations for medical devices with a continuous improvement programs. Lead, develop, implement and maintain quality systems for controlling product quality using process capability, inspection, auditing and statistical analysis. Lead, develop, implement and maintain an effective quality system for preventing nonconforming product and/or its recurrence using quality planning, material review, corrective action and quality reporting. Responsible for selection, interviewing and onboarding of new hires and develop a relevant training program and plan for all site personnel. Responsible for leading, driving and enforcing quality programs in collaboration with manufacturing team. Resolve customer concerns, complaints and provide feedback on quality issues. Analyze daily and monthly quality reports and develop tests to improve product quality. Manage day to day department activities. Support company quality policy and objectives. Ensure products produced meets customer expectations (approve quality specifications) and regulatory requirements Lead customer audits, ISO audits and Internal audits Achieve financial objectives (maintain department salaries within budget, prepare the Quality budget, schedule the expenditures) Follow and report of the site quality performances from a quality standpoint and ensure alignment with Business Unit and manage continuous improvement for product quality In cooperation with the Sites Quality Coordinator, develop and implement Quality Objectives in line with objectives of the business unit Lead and influence a quality mindset to quality and operations to maintain, improving and maintaining quality system requirements. Continually improve quality through analyzing, identifying, and eliminating root causes. Such improvements include reducing defects, decreasing scrap, reducing waste, and improving outputs. Apply and evaluate testing and inspection methods; including the identification of requirements for improvements. Develop and implement quality cost reduction concepts and techniques. Manage department resources, including work assignments, training, cross training, personnel issues, hiring decisions, performance appraisals, motivation, efficiency, capacity and accuracy of work. Ensure shift-to-shift communication. Provide a safe work environment and resolve any safety issues that arise. Perform other job-related duties as assigned." We need to split into bullet items. Each sentence seems a duty. We'll create
- for each.
Now Core Competencies list: "Facilitation Conflict Management Fostering Learning Information Gathering & Processing Interactive Communication Partnering Relationship Building Research Teamwork Writing Skills Attention to detail Adaptability Concern for Safety Proactive and self-motivated Strong time management with priority setting skills Client focused". These are separated by spaces; we need to split into items. Probably each phrase separated by space but some have spaces inside like "Information Gathering & Processing". We'll split by spaces but need to keep phrases with & as one. Could treat each as separate item: Facilitation, Conflict Management, Fostering Learning, Information Gathering & Processing, Interactive Communication, Partnering Relationship Building, Research, Teamwork, Writing Skills, Attention to detail, Adaptability, Concern for Safety, Proactive and self-motivated, Strong time management with priority setting skills, Client focused.
Now Knowledge, Skills, and Abilities list: many items separated by periods? Let's extract:
"Expert knowledge and interpretation of ISO 13485, ISO 9000 standards, 21 CFR 820 and cGMP compliance. Ability to lead, implement quality management systems as applicable to ISO and 21 CFR regulations. Demonstrate understanding of industry standard validation tools and techniques. Demonstrated ability of metrology and basic inspection tools, metrology and injection molding workmanship standards. Ability to develop/conduct quality related training programs. Effectively communicate in both verbal and written. Good organizational skills. Excellent English communication skills (both written and verbal). Fluency in Spanish a plus. Understanding and use of metrology equipment. Ability to read drawings and good understanding of geometric tolerancing. Knowledge of processing engineering polymers is a plus. Exceptional leadership skills which include ability to prioritize, lead, direct, train, and motivate staff. Ability to influence peers. Excellent planning and organizational skills. Good analytical, problem-solving and math skills. Six Sigma and Lean knowledge a plus. Understanding and use of sampling plans, Gauge R&R, statistical techniques and SPC. Ability to use personal computer and Windows-based software (Outlook, Word and Excel preferred). Use of PC-DMIS metrology software, IQMS manufacturing software and Minitab a plus."
We'll split each sentence as bullet.
Education and/or Experience: "Bachelor’s degree desirable, four-year college degree (preferably in a sciences chemical, pharmacy, plastics or engineering field) or equivalent combined college/work experience. At least 5 years of leading and implementing quality systems in a pharmaceutical or medical device environment Manufacturing experience in injection molding plastics industry (or equivalent industry) is a plus."
We'll split sentences.
Now we need sections: Responsibilities, Requirements (or Qualifications), Skills. Could also have "Education and Experience" as part of Requirements. We'll make sections: Responsibilities, Requirements, Skills. Under Requirements we can include Education/Experience and maybe Knowledge/Skills? But Skills section should contain core competencies and knowledge/skills/abilities. Let's decide:
- Responsibilities: essential job functions.
- Requirements: Education and/or Experience (maybe also mention required knowledge? but that's more skill). We'll keep just education/experience.
- Skills: Core Competencies + Knowledge, Skills, and Abilities.
We must not create Benefits/Pay/Schedule.
Now produce HTML:
Responsibilities
- ... ...
Requirements
- ... ...
Skills
- ... ...
- for each.
Now Core Competencies list: "Facilitation Conflict Management Fostering Learning Information Gathering & Processing Interactive Communication Partnering Relationship Building Research Teamwork Writing Skills Attention to detail Adaptability Concern for Safety Proactive and self-motivated Strong time management with priority setting skills Client focused". These are separated by spaces; we need to split into items. Probably each phrase separated by space but some have spaces inside like "Information Gathering & Processing". We'll split by spaces but need to keep phrases with & as one. Could treat each as separate item: Facilitation, Conflict Management, Fostering Learning, Information Gathering & Processing, Interactive Communication, Partnering Relationship Building, Research, Teamwork, Writing Skills, Attention to detail, Adaptability, Concern for Safety, Proactive and self-motivated, Strong time management with priority setting skills, Client focused.
Now Knowledge, Skills, and Abilities list: many items separated by periods? Let's extract:
"Expert knowledge and interpretation of ISO 13485, ISO 9000 standards, 21 CFR 820 and cGMP compliance. Ability to lead, implement quality management systems as applicable to ISO and 21 CFR regulations. Demonstrate understanding of industry standard validation tools and techniques. Demonstrated ability of metrology and basic inspection tools, metrology and injection molding workmanship standards. Ability to develop/conduct quality related training programs. Effectively communicate in both verbal and written. Good organizational skills. Excellent English communication skills (both written and verbal). Fluency in Spanish a plus. Understanding and use of metrology equipment. Ability to read drawings and good understanding of geometric tolerancing. Knowledge of processing engineering polymers is a plus. Exceptional leadership skills which include ability to prioritize, lead, direct, train, and motivate staff. Ability to influence peers. Excellent planning and organizational skills. Good analytical, problem-solving and math skills. Six Sigma and Lean knowledge a plus. Understanding and use of sampling plans, Gauge R&R, statistical techniques and SPC. Ability to use personal computer and Windows-based software (Outlook, Word and Excel preferred). Use of PC-DMIS metrology software, IQMS manufacturing software and Minitab a plus."
We'll split each sentence as bullet.
Education and/or Experience: "Bachelor’s degree desirable, four-year college degree (preferably in a sciences chemical, pharmacy, plastics or engineering field) or equivalent combined college/work experience. At least 5 years of leading and implementing quality systems in a pharmaceutical or medical device environment Manufacturing experience in injection molding plastics industry (or equivalent industry) is a plus."
We'll split sentences.
Now we need sections: Responsibilities, Requirements (or Qualifications), Skills. Could also have "Education and Experience" as part of Requirements. We'll make sections: Responsibilities, Requirements, Skills. Under Requirements we can include Education/Experience and maybe Knowledge/Skills? But Skills section should contain core competencies and knowledge/skills/abilities. Let's decide:
- Responsibilities: essential job functions.
- Requirements: Education and/or Experience (maybe also mention required knowledge? but that's more skill). We'll keep just education/experience.
- Skills: Core Competencies + Knowledge, Skills, and Abilities.
We must not create Benefits/Pay/Schedule.
Now produce HTML: