Jobs · Quality Assurance · Illinois

Manager, Quality Engineering,

Baxter International Inc. · Round Lake, IL · 1 mo ago
Quality Assurance$112k–$154k/yrFull-time
We need to output HTML fragment with sections: About the role? The posting includes a summary paragraph: "Summary Leads the Quality Engineering function ...". That's like a description. We can treat that as a section heading "About the role" or "Summary". 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. We need to extract sections: About the role (summary), Responsibilities (Essential Duties And Responsibilities), Qualifications (Qualifications, Education And/or Experience). Possibly Skills? The qualifications includes skills; we could combine into Qualifications. Benefits: there is a US Benefits section with details. Pay: there is salary range. Schedule: not mentioned. So we include Pay and Benefits sections. We must not include boilerplate like EEO, Fraud notice, etc. We need to preserve all substantive info: summary, duties list, qualifications list, education/experience, benefits details, pay range. We need to format as HTML fragment only, no or . Use

    headings. We need to use
    • for any list of duties/requirements/benefits. For prose use

      . We need to decide how to structure each section. Section About the role: could be a

      containing the summary paragraph. Section Responsibilities: list each duty as

    • . The duties are many sentences separated by periods. We'll break each bullet. Section Qualifications: could include both the qualifications paragraph and education/experience. Might split into two sub-sections? But instruction: prefer few substantive sections over many thin ones. Could combine Qualifications and Education/Experience into one Qualifications section with lists. We need to preserve all details: Expert knowledge of cGMP validation..., Demonstrated people leadership..., Strong strategic planning..., Ability to maintain QA independence..., Excellent written..., Proven success..., Working knowledge..., Candidate must meet all applicable site safety..., Education And/or Experience: Bachelor’s degree..., 8 or more years..., Prior experience..., ASQ CQE..., etc. We could make two lists: one for "Qualifications" (skills, abilities) and another for "Education and Experience". But that would be two sections under same heading? Could use

      Qualifications

      then

      for the paragraph describing expertise, then

        for the bullet list of specific qualifications, then another
          for education/experience? Might be okay. Benefits: The US Benefits section includes many items: medical and dental coverage day one, insurance for basic life, accident, short-term and long-term disability, business travel accident insurance. Financial and retirement benefits: ESPP, 401(k) RSP with options for employee contributions and company matching. Flexible Spending Accounts, educational assistance programs, time-off benefits such as paid holidays, paid time off ranging from 20 to 35 days based on length of service, family and medical leaves of absence, paid parental leave. Additional benefits: commuting benefits, Employee Discount Program, EAP, childcare benefits. We need to list these as
          • . Could group into categories but still list each benefit. Pay: The estimated base salary $112,000 - $154,000 annually. Also mention discretionary bonuses. We'll include that as

            . We must not include filler like "commensurate with experience". Not present. We must not include duplicated lines. We must remove boilerplate: EEO, Fraud notice, Reasonable Accommodations, etc. We must not include application instructions. Now craft HTML. Start with

            About the role

            then

            Summary Leads the Quality Engineering function responsible for independent oversight of the site validation program and governance of the plant data integrity program. Sets strategy, standards, risk tolerance, and performance expectations; ensures effective QA partnership with Engineering, Facilities, Operations, CSV, laboratories, and system owners; and represents the QA oversight of these programs to site leadership and regulatory agencies. The manager ensures accountable owners execute validation and remediation work while Quality Engineering personnel maintain independent review, approval, escalation, and governance.

            Then

            Responsibilities

            then
              with each duty. Duties list from "Establish and maintain the site strategy..." to "Develop capability, succession plans, training, and standardized tools for Quality Engineering and cross-functional partners." and "Manage resources and continuous-improvement priorities to maintain compliant, efficient oversight without compromising QA independence." We need to split each sentence as bullet. Let's extract: - Establish and maintain the site strategy, governance model, procedures, and decision rights for independent QA oversight of validation and plant-level data integrity. - Lead, develop, and performance-manage the Quality Engineering team; assign oversight based on project risk, complexity, and business priority. - Ensure Engineering, Facilities, Operations, CSV, laboratories, and system/process owners maintain clear accountability for validation authoring and execution, technical operation, vulnerability remediation, and sustained control effectiveness. - Approve or delegate approval of validation master plans, high-risk protocols and reports, critical deviations, revalidation strategies, major change controls, and continued use or release decisions. - Chair or sponsor validation and data integrity governance forums; set risk-based priorities across the plant system inventory and resolve cross-functional ownership or resource conflicts. - Ensure the data integrity program is aligned with GAMP 5, 21 CFR Part 11, ALCOA+ principles, corporate standards, and current regulatory expectations. - Review program health through metrics, audits, periodic reviews, remediation aging, deviation trends, audit-trail-review performance, and effectiveness checks; escalate risks to site leadership. - Ensure remediation plans have accountable operational owners, appropriate milestones, interim controls, documented risk acceptance, and independent QA verification of sustainable closure. - Represent validation and data integrity programs, in partnership with system owners, during FDA and other regulatory inspections, customer audits, governance reviews, and regulatory submissions. - Develop capability, succession plans, training, and standardized tools for Quality Engineering and cross-functional partners. - Manage resources and continuous-improvement priorities to maintain compliant, efficient oversight without compromising QA independence. Now Qualifications section. We have paragraph: "Expert knowledge of cGMP validation, computerized-system assurance, GAMP 5, 21 CFR Part 11, ALCOA+ principles, data integrity governance, quality systems, and contemporary regulatory expectations.Demonstrated people leadership and ability to build high-performing technical teams.Strong strategic planning, risk-based decision-making, governance, influencing, negotiation, and conflict-resolution skills.Ability to maintain QA independence while creating effective partnerships with Engineering, Facilities, Operations, CSV, laboratories, and business leadership.Excellent written and oral communication skills, including executive and regulatory presentations.Proven success leading complex programs, inspections, remediation governance, and cross-functional organizational change.Working knowledge of statistics, process capability, risk-management tools, and electronic quality systems.Candidate must meet all applicable site safety and occupational requirements." We could turn each sentence into bullet or keep as prose? The instruction: Use
              • for any list of duties/requirements/benefits. This is a list of requirements/qualifications, so we should use
                • . So break each sentence. Sentences: - Expert knowledge of cGMP validation, computerized-system assurance, GAMP 5, 21 CFR Part 11, ALCOA+ principles, data integrity governance, quality systems, and contemporary regulatory expectations. - Demonstrated people leadership and ability to build high-performing technical teams. - Strong strategic planning, risk-based decision-making, governance, influencing, negotiation, and conflict-resolution skills. - Ability to maintain QA independence while creating effective partnerships with Engineering, Facilities, Operations, CSV, laboratories, and business leadership. - Excellent written and oral communication skills, including executive and regulatory presentations. - Proven success leading complex programs, inspections, remediation governance, and cross-functional organizational change. - Working knowledge of statistics, process capability, risk-management tools, and electronic quality systems. - Candidate must meet all applicable site safety and occupational requirements. Then Education And/or Experience: "Bachelor’s degree in Engineering, Science, Computer Science, or a related technical discipline required.8 or more years of progressive experience in validation, quality engineering, computerized-system assurance, data integrity, or QA within a cGMP-regulated industry, including people or program leadership.Prior experience participating in regulatory inspections and complex remediation programs desired.ASQ CQE, CSQE, CQA, Six Sigma, or comparable professional certification highly desirable." We could also list as bullets. - Bachelor’s degree in Engineering, Science, Computer Science, or a related technical discipline required. - 8 or more years of progressive experience in validation, quality engineering, computerized-system assurance, data integrity, or QA within a cGMP-regulated industry, including people or program leadership. - Prior experience participating in regulatory inspections and complex remediation programs desired. - ASQ CQE, CSQE, CQA, Six Sigma, or comparable professional certification highly desirable. We could combine under same Qualifications heading, but maybe better to have two subheadings? But instruction: prefer few sections. Could keep one Qualifications section with two lists: one for "Qualifications" and another for "Education and Experience". But we could just make one list combining all items. That would be okay. Thus Qualifications section
                  • with all items from both paragraphs. Now Benefits section:

                    Benefits

                    then
                      list each benefit. We need to parse the benefits paragraph. Text: "Baxter offers comprehensive compensation and benefits packages for eligible roles. Our health and well-being benefits include medical and dental coverage that start on day one, as well as insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance. Financial and retirement benefits include the Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount, and the 401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching. We also offer Flexible Spending Accounts, educational assistance programs, and time-off benefits such as paid holidays, paid time off ranging from 20 to 35 days based on length of service, family and medical leaves of absence, and paid parental leave. Additional benefits include commuting benefits, the Employee Discount Program, the Employee Assistance Program (EAP), and childcare benefits." We need to list each distinct benefit. Let's extract: - Medical and dental coverage that start on day one - Insurance coverage for basic life - Insurance coverage for accident - Insurance coverage for short-term disability - Insurance coverage for long-term disability - Business travel accident insurance - Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount - 401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching - Flexible Spending Accounts - Educational assistance programs - Paid holidays - Paid time off ranging from 20 to 35 days based on length of service - Family and medical leaves of absence - Paid parental leave - Commuting benefits - Employee

Similar jobs

Manager, Quality Engineering

Integra LifeSciencesPlainsboro, NJ· 1 mo ago
Quality Assurance$109k–$150k/yrapply on integralife.wd1.myworkdayjobs.com