New · posted Oct 15
Haemonetics · Medical Devices
Senior Manager, Quality Assurance
- Clinton, PA
- On-site
- Full-time
- Manager
Open until filled
The role
Job Details
Haemonetics is hiring a Senior Manager, Quality Assurance - Site based out of its Center of Excellence in Clinton, PA. This person is responsible for effective implementation and maintenance of Quality Systems and compliance programs in accordance with MDD 93/42/EEC, ISO 13485, CMDR, and applicable QSRs (21 CFR 820, 210, 211) for a specific plant or business unit. This position leads Quality Systems functions and partners closely with Plant Management and cross-functional stakeholders to ensure compliance with quality and regulatory requirements. The role collaborates with teams responsible for CAPA, Complaints, Environmental Programs, Sterilization, Management Review, Change Control, Design Review, and manufacturing support to drive quality performance and continuous improvement.
What you need
Bachelor's degree in Engineering, Life Sciences, Quality, or a related technical discipline; advanced degree (MS, MBA, or equivalent) preferred.
8+ years of progressive Quality Assurance or Quality Systems experience within a regulated industry.
5+ years of leadership experience managing quality teams.
Demonstrated experience with FDA regulations, ISO 13485, MDSAP, and global regulatory requirements.
Medical device, biotechnology, pharmaceutical, or combination product experience.
Experience supporting manufacturing operations and quality system compliance.
Experience leading multiple quality functions, including CAPA, Complaints, Design Assurance, Audits, Validation, and Supplier Quality.
Experience with MDR and/or IVDR regulations strongly preferred.
Six Sigma Green Belt, Black Belt, ASQ certification, or equivalent quality certification preferred.
What you'll do
Contributes to defining short-term and long-term strategic direction for the QA function, facility, and corporation.
Leads the implementation, maintenance, and continuous improvement of the site's Quality Management System, ensuring compliance with applicable regulatory and quality standards, including but not limited to, MDD 93/42/EEC, ISO 13485, CMDR, and QSRs.
Serves as the site's subject matter expert for the Haemonetics Quality Management System.
Promotes awareness and understanding of regulatory and customer requirements throughout the organization.
Oversees site quality system compliance through internal audits, management reviews, quality meetings, KPI monitoring, and trend analysis to identify risks and drive continuous improvement.
Collaborates with Plant Management to ensure design and engineering changes are effectively implemented through quality planning, including appropriate verification and validation activities.
Partners with Plant Management to proactively identify and resolve quality issues, integrating quality requirements into manufacturing processes and operations.
Initiates and monitors corrective and preventive actions (CAPAs) to ensure timely resolution of quality issues and ongoing compliance with written specifications.
Represents Haemonetics during 2nd-party (e.g., customer, contractor) and 3rd-party (e.g., FDA, ISO) quality system audits and inspections.
Oversees incoming, in-process, and finished goods inspection activities for designated facilities and product families.
May be accountable for establishing and managing inspection, sampling, and testing programs to ensure products meet specifications from raw material through finished goods.
Develops, mentors, and leads Quality team members, fostering technical expertise, accountability, and continuous professional development.
Pay and benefits
$124,300 – $211,700 a year
Employer providedPay Transparency
The pay range for this role is:
$124,300.00-$211,700.00/Annual
The base pay actually offered to the successful candidate will take into account, without limitation, the candidate’s location, education, job-knowledge, skills, and experience in prior relevant roles.
Incentives may also be provided as part of Haemonetics’ employee compensation. For sales roles, employees will be eligible for sales incentive (i.e., commission) under the applicable plan terms. For non-sales roles, employees will be eligible for a discretionary annual bonus, the target amount of which varies based on the applicable role, to be governed by the applicable plan terms. Employees may also be eligible to participate in the Company’s long-term incentive plan, with eligibility and target amount dependent on the role.
In addition to compensation, the Company offers a competitive suite of benefits to its employees, including without limitation, a 401(k) with up to a 6% employer match and no vesting period, an employee stock purchase plan, “flexible time off” for salaried employees and, for hourly employees, accrual of three to five weeks’ vacation annually (based on tenure), accrual of up to 64 hours (annually) of paid sick time, paid and/or floating holidays, parental leave, short- and long-term disability insurance, tuition reimbursement, and/or health and welfare benefits.
Depending on your location, you may be eligible for more detailed information related to the compensation and benefits related to this job posting. If you believe you may be entitled to such information by law, you may contact 1-781-348-7777, Monday through Friday, 7:30 a.m. – 5 p.m. ET or email [email protected].
We are constantly looking to add to our core talent. If you are seeking a career that is challenging and rewarding, a work environment that is diverse and dynamic, look no further — Haemonetics is your employer of choice.
6%
401(k) with up to 6% employer match, no vesting
Employee stock purchase plan
Flexible time off
Parental leave
Short- and long-term disability insurance
Tuition reimbursement
Where you'll work
Clinton, PAOn-siteOpen in Maps (opens in a new tab)
More jobs in Clinton, PAJob intelligence
The context around this role
Live data · October 15, 2026
Salary intelligence
How the pay compares
This role's midpoint is 10% above the US median for Quality Assurance roles at this level.
This roleEmployer provided
Manager roles in Pennsylvania9 roles publishing pay
Manager roles in the US105 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $124,300 | — | $211,700 |
| Pennsylvania (middle half) | $139,500 | $145,000 | $163,500 |
| All US (middle half) | $126,000 | $153,000 | $167,500 |
This role: Haemonetics's own published range. Comparisons: the base pay employers published on open Quality Assurance roles at the same level on Regulatory Jobs, October 15, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Quality Assurance
The general path across 845 open Quality Assurance roles on Regulatory Jobs, with the titles they carry most. Not Haemonetics's own promotion track.
Career resources on Quality Assurance
Skills DNA
What this role leans on
How many of the posting's 23 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- GMP and compliance11
- Quality systems and risk9
- Collaboration and leadership6
- Investigations and CAPA2
- Validation and qualification2
- Lab testing and methods1
- Regulatory submissions1
Regulatory intelligence
The rules behind this role
Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.
- FDA21 CFR Part 820 (QMSR)(official source, opens in a new tab)FDA quality management system regulation for medical devices
- European UnionEU MDR (Regulation 2017/745)(official source, opens in a new tab)The EU Medical Device Regulation
- European UnionEU IVDR (Regulation 2017/746)(official source, opens in a new tab)The EU In Vitro Diagnostic Medical Devices Regulation
- ISOISO 13485(official source, opens in a new tab)Quality management systems for medical devices
- FDA and partnersMDSAP(official source, opens in a new tab)The Medical Device Single Audit Program
Company hiring pulse
Haemonetics on Regulatory Jobs
- 4
- Open roles
- 4
- Distinct roles
- 2
- Locations
By discipline
- Quality4 100%
By level
- Manager2 50%
- Senior & Principal1 25%
- Associate & Specialist1 25%
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Senior Manager, Quality Assurance at Haemonetics
Open until filled. $124K–$212K a year, employer provided.