PCI Pharma Services

PCI Pharma Services

Sr. Manager, Quality Engineering ADD

Rockford, IL, USA · Senior · Full-time

Sponsorship not specified$109k-$136kDetected 22 days ago
StatisticsComplianceProcess ImprovementERPFDA RegulatoryMedical DevicesLeadershipCritical ThinkingTime ManagementMentoringWritingMicrosoft OfficeLean Manufacturing

About the role

  • Bridge to thousands of biopharma companies and their patients.
  • Final offer amounts are determined by multiple factors, including but not limited to specific and relevant experience, education, credentials, geography, and subject matter expertise.
  • Let's talk future Equal Employment Opportunity (EEO) Statement: PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer.

Responsibilities

  • Provides strategy and leadership over the Quality Engineering (QE) teams at both Rockford Linden sites that are involved in supporting design transfer/control/assurance, risk management, statistical analysis of data, deviations, complaints, change management, and quality improvement projects.
  • Leads QE team to support New Product Introduction and tech transfer for product launches as well as supporting the sustaining commercialized products
  • Serve as subject matter expert (SME) and process owner for the Design Control and Risk Management procedures within the Quality Management System, including a risk management program aligned to ISO 14971
  • Provide high level guidance on complex design validation and verification (V&V) strategies, sampling plans and root cause investigations for design failure.
  • Oversee the feedback loop between Post-Market Surveillance (Complaints) and internal or external design assurance teams to trigger necessary design changes or CAPAs based on field reports.
  • Serve as the final Quality approver for major "Stage Gate" transitions, ensuring all design inputs, outputs, and transfer activities are complete and compliant.
  • Ensure design assurance strategies align with evolving global standards, including ISO 13485 and FDA 21 CFR 820
  • Apply scientific statistical analysis techniques to proactively identify trends, identify root causes and implement actions to mitigate recurrence.
  • Leads a group up to 10 direct reports across multiple sites.
  • Oversees and provides input for statistical assessment of data to drive improvements.

Requirements

  • The requirements listed below are representative of the knowledge, skill, and/or ability required for the stated position.
  • College or Trade Degree required (engineering degree or related scientific degree).
  • Demonstrated proficiency with personal computers, business software (e.g., MS Office) and technical software (ERP and eQMS systems).
  • The requirements listed below are representative of the knowledge, skill, and/or ability required for the stated position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
  • Required:
  • College or Trade Degree required (engineering degree or related scientific degree). Must have a minimum of 5+ years of experience in an FDA regulated industry with strong preference to medical device or combination products.
  • Demonstrated proficiency with personal computers, business software (e.g., MS Office) and technical software (ERP and eQMS systems). Ability to create, use and interpret scientific tables, charts, and graphs.
  • Advanced Computer Skills: Ability to perform the most complex computer tasks and operate various computer programs.
  • Analytical ability to drive effective Root Cause Analysis (RCA) and critical thinking for complex problem solving.
  • Preferred:
  • The hiring rate for this position is $108,690-$136,200 plus eligibility for an annual 10% performance bonus. Final offer amounts are determined by multiple factors, including but not limited to specific and relevant experience, education, credentials, geography, and subject matter expertise. PCI offers full-time employees a competitive benefits package that includes paid time off, health insurance coverage (including dental and vision), a flexible spending account, and a 401(k) plan.

Skills

  • Full Professional Proficiency: Ability to speak, read, and write fluently and accurately on all levels pertinent to professional needs.
  • Possesses excellent organizational, time management and multi-tasking skills to meet commitments and deadlines.
  • Prior experience in technical writing and utilizing root cause analysis tools is required.
  • Critical thinking skills along with a strong collaborative approach is required.
  • Lean Six Sigma or other formal process improvement skillsets are highly desirable.
  • Technical knowledge and experience around Test Method validation, MSA, and Medical Devices processes is preferred.
  • The hiring rate for this position is $108,690-$136,200 plus eligibility for an annual 10% performance bonus.
  • Let's talk future
  • Equal Employment Opportunity (EEO) Statement:
  • PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer.
  • At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies.

Compensation

  • The hiring rate for this position is $108,690-$136,200 plus eligibility for an annual 10% performance bonus.

Benefits

  • Creates a "learning" culture that enables individuals to reach their maximum potential and builds the capability of the organization and generates energy, enthusiasm and commitment from others.

Company info

  • Together, delivering life-changing therapies.
  • We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level.
  • We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.
  • Participates as a member in various steering committees to guide and influence the company's focus on new products, new customers, and strategic initiatives.

Equal opportunity

  • We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.

Visa & Work Authorization

  • We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual o
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This listing is sourced directly from PCI Pharma Services's careers page and normalized into a canonical job model.