Manager, Post Market Quality & Compliance

We need to output HTML fragment with sections: About the role? Actually the posting includes "Who We Are", "About the Opportunity", "Key Responsibilities", "About the Right Candidate", "Qualifications", "Preferred Qualifications", "Compensation and Benefits". Also maybe "Values" and "Behaviors". The instruction: use

for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). Use

• for any list of duties/requirements/benefits, and

  for prose. Do NOT repeat the job title as a heading (the page already shows it) and do NOT put Job ID / requisition numbers as headings — fold minor metadata into a short

  or drop it. Preserve ALL substantive information; do NOT invent or summarize away detail. Remove cookie/navigation/legal/EEO/equal-opportunity/scam-warning boilerplate, duplicated lines, and application instructions. IMPORTANT: include a section ONLY when the posting has real, specific content for it — never emit a heading followed by filler/placeholder text (e.g. "commensurate with experience", "not specified", "N/A", "varies", "TBD") and never create Pay/Schedule/Benefits sections unless the posting actually states them. Prefer a few substantive sections over many thin ones. Output ONLY the HTML fragment — no /, no markdown code fences. Thus we need to decide which sections to include based on content. We have: - Who We Are: mission and values driven company, remote team. This is substantive. Could be a section "About the Company" maybe but they said headings like About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. But they gave examples, not strict list. We can use headings like "About the Company" as

  . Probably okay. - About the Opportunity: description of role. Could be "About the Role". Use

  About the Role

  . - Key Responsibilities: large list. Use

  Responsibilities

  with
  • items. - About the Right Candidate: maybe "Qualifications" or "Requirements". They have "Qualifications" and "Preferred Qualifications". Could combine into Requirements section. But they said use headings like Qualifications, Skills, Benefits, Pay, Schedule. So we can have

    Qualifications

    for required qualifications, and maybe

    Preferred Qualifications

    as separate? But they said prefer few substantive sections over many thin ones. Could combine required and preferred into one Qualifications section with sublists? But we need to preserve all info. Could have

    Qualifications

    with required list, then

    Preferred Qualifications

    as another heading. That's two sections but still okay. - Compensation and Benefits: they gave salary range and benefits list. So we need

    Compensation and Benefits

    or separate Pay and Benefits? They said use headings like Benefits, Pay. Could do

    Pay

    for salary range, and

    Benefits

    for benefits list. But they said never create Pay/Schedule/Benefits sections unless posting actually states them. It does state compensation and benefits. So we can include both. - Values and Behaviors: they listed values and behaviors. Could be a section "Values and Behaviors". Might be considered Skills? Not exactly. Could be a section "Company Values". Might be okay. We need to remove boilerplate: EEO statement at end. Remove that. Also remove duplicated lines: "Other duties as assigned." appears twice? Actually appears under Key Responsibilities: "10 %: Other duties as assigned Other duties as assigned." We should keep only one instance? The instruction: remove duplicated lines. So we should keep only one "Other duties as assigned." maybe as a bullet under Responsibilities? Actually it's a separate bullet under Responsibilities? It says "10 %: Other duties as assigned Other duties as assigned." Likely a mistake; we should keep one "Other duties as assigned." as a bullet. Also remove "You will adhere to our company's values and behaviors and incorporate them in your interactions with colleagues and customers." That's maybe part of Values/Behaviors but could be kept. We need to preserve all substantive information. Let's extract content. Who We Are: "We're a mission and values driven company with tremendous dedication to our customers. Our 100% remote team, spread across the US and Canada, is dedicated to a common goal – to revolutionize healthcare through innovation, collaboration, and commitment to our core values and behaviors." About the Opportunity: "Synthesis Health is looking for a stellar Senior Post-Market Quality Manager who will be responsible for leading, implementing and continuously improving the post-market quality processes and program for the Company's Software as a Medical Device (SaMD) products. The role provides quality leadership across the full post-market life cycle including complaint handling, adverse event assessment, trend analysis, nonconformances, CAPA, field actions, quality monitoring, and recalls. The role also leads the Safety Committee that evaluates and investigates identified safety and potential compliance issues with non-medical device products. The position partners closely with Regulatory Affairs, Chief Medical Officer, Product, Engineering, and Customer Support/Service and other cross-functional teams to ensure timely identification, investigations, escalation, and resolution of product quality and safety issues. The ideal candidate brings strong experience with MDSAP quality systems, and post market surveillance of radiology-related SaMD products, combined with an understanding of software development, QA, cloud-based products, unique quality considerations associated with SaMD, and radiology. This role is highly hands-on and requires the ability to independently lead complex investigations and quality initiatives without direct reports." Key Responsibilities: 90%: Quality Management (list). Then 10%: Other duties as assigned. We need to convert the list into bullet points. The list is long sentences each starting with a verb. We'll make each sentence a
  • . Ensure we keep all details. Let's copy the responsibilities text: "Own and continuously improve post-market quality SOPs and tools used for effective and compliant post market surveillance Lead assessment and investigation of product complaints, including problem definition, risk assessment, investigation strategy, root cause analysis, and resolution Evaluate complaints and product events for reportability, escalation and potential patient or user impact in partnership with SMEs. Monitor post-market quality data to identify emergent issues, adverse trends, recurring problems and opportunities for product or process improvements. Establish and maintain meaningful quality metrics, dashboards and management reporting Ensure appropriate documentation, traceability, and timely closure of post-market quality records. Lead complex and cross functional CAPAs arising from post-market data, complaints, audits, non-conformances and other quality signals Facilitate root-cause analysis using appropriate problem-solving methodologies and drive actions to completion Develop and oversee effective CAPAs Identify systemic issues and recommend improvements to products, processes, controls and the QMS Partner with Engineering and Product to assess software defects, anomalies, and product issues from a quality and safety perspective Support evaluation of software changes, including assessment of potential post-market impact and quality implications Participate in investigations involving software functionality, data integrity, interoperability, usability, cybersecurity, and other product specific risks as applicable Help establish effective interfaces between post-market quality SOPs and software development, release, change-control and risk management processes Lead quality compliance activities associated with product correction, removals, customer notifications, and other field actions. Provide QMS and regulatory compliance input into escalation decisions based on product risk, severity, frequency and available evidence Coordinate cross-functional execution of quality-related field actions and ensure appropriate documentation and follow-through Identify and communicate significant quality trends or risks for Management Reviews and to leadership. Translate post-market regulatory requirements into actionable information; support training program to improve effectiveness of QMS training. Provide quality guidance, mentorship and training Represent post-market quality in relevant product, management reviews, and audits Maintain and improve relevant procedures, work instructions, templates and associated quality system processes Support internal and external audits and provide evidence of effective post-market quality processes Ensure activities are conducted in accordance with applicable medical device regulations, standards and company procedures Support inspection readiness and respond to audit and/or regulatory observations Identify opportunities to simplify, automate and strengthen quality processes while maintaining compliance." Then "10 %: Other duties as assigned Other duties as assigned." We'll keep one bullet: "Other duties as assigned." About the Right Candidate: "You can work in a fast-paced environment and juggle multiple projects with overlapping deadlines." Qualifications: "A bachelor's degree plus advanced training and certifications in MDSAP Quality Management Systems, post-market surveillance requirements of FDA, Health Canada and EUMDR. 6+ years experience in Quality within the healthcare or life sciences industry, including internal and external audits, field corrections, adverse event reporting, data collection. Knowledge of ISO 13485 and application in SaMD Knowledge of MDSAP program Knowledge of relevant FDA, Health Canada medical device regulations and implementation for SaMDs. Knowledge of EUMDR Collaborate with both technical and non-technical team members. Quickly build trusting relationships with both internal and external stakeholders. Adjust quickly to changing priorities. Strong analytical and critical thinking skills. Excellent people and management skills in interacting with staff, colleagues, cross-functional teams and third parties. An eagerness to learn about new trends, tools, and technologies, and to continually consider how they will influence our products." Preferred Qualifications: "Bachelors in computer science, engineering, or a relevant discipline; Masters degree in relevant discipline. 6+ years' experience working in quality assurance/post market quality systems for a SaMD company. Experience working in an agile environment. Experience applying technology tools (including AI) to improve productivity and efficiency of processes and records" Values and Behaviors: "You will adhere to our company's values and behaviors and incorporate them in your interactions with colleagues and customers. Values: Clinical service first. Collaborate with our customers. Listen, respect, learn. Innovate to excel. Behaviors: Be nice. Be creative. Be honest. Be helpful." Compensation and Benefits: "Compensation is paid in the currency of the country where the individual is hired. For this position, the salary range is $100,000 - $120,000 USD. Other benefits include but not limited to: Medical, Dental, Vision, "Use as needed" vacation policy, and participation in our employee option program." We need to remove EEO statement at end. Now decide sections. Potential sections: - About the Company (Who We Are) - About the Role (About the Opportunity) - Responsibilities (Key Responsibilities) - Qualifications (required) - Preferred Qualifications - Values and Behaviors - Compensation (Pay) - Benefits But they said prefer few substantive sections over many thin ones. Could combine Qualifications and Preferred Qualifications into one "Qualifications" section with subheadings? But we cannot use

    maybe? Only

    for section headings. Could we embed preferred qualifications as a

    within Qualifications? That would be okay. But we need to preserve all info; we can list required qualifications as bullet list, then a note "Preferred qualifications:" then bullet list. That's still one section. Similarly, Values and Behaviors could be a section "Company Values". Could combine with something else? Maybe not. Compensation and Benefits could be two sections: Pay and Benefits. But they said prefer few sections; maybe combine into one "Compensation and Benefits" section with both pay range and benefits list. Thus we could have sections: - About the Company - About the Role - Responsibilities - Qualifications (including required and preferred) - Values and Behaviors - Compensation and Benefits That's six sections. Now we need to format. Use

    for each heading. Inside each section, use

    for prose,